Methods, systems and devices for cardiac valve repair

ABSTRACT

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient&#39;s arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 12/883,095 filed Sep. 15, 2010, which claims the benefit of priorityunder 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No.61/243,459, filed Sep. 17, 2009. This application is also acontinuation-in-part of co-pending U.S. patent application Ser. No.11/349,742, filed on Feb. 7, 2006, which claims the benefit of priorityunder 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No.60/650,918 entitled “Methods, Systems and Devices for Cardiac ValveRepair,” filed Feb. 7, 2005, and U.S. Provisional Patent ApplicationSer. No. 60/692,802 entitled “Methods, Systems and Devices for CardiacValve Repair,” filed Jun. 21, 2005. Priority of the aforementionedfiling dates is hereby claimed, and the full disclosures of theaforementioned applications are hereby incorporated by reference intheir entirety.

BACKGROUND

The present invention relates generally to medical methods, devices, andsystems. In particular, the present invention relates to methods,devices, and systems for the endovascular or minimally invasive surgicalrepair of the atrioventricular valves of the heart, particularly themitral valve.

Mitral valve regurgitation is characterized by retrograde flow from theleft ventricle of a heart through an incompetent mitral valve into theleft atrium. During a normal cycle of heart contraction (systole), themitral valve acts as a check valve to prevent flow of oxygenated bloodback into the left atrium. In this way, the oxygenated blood is pumpedinto the aorta through the aortic valve. Regurgitation of the valve cansignificantly decrease the pumping efficiency of the heart, placing thepatient at risk of severe, progressive heart failure.

Mitral valve regurgitation can result from a number of differentmechanical defects in the mitral valve. The valve leaflets, the valvechordae which connect the leaflets to the papillary muscles, or thepapillary muscles themselves may be damaged or otherwise dysfunctional.Commonly, the valve annulus may be damaged, dilated, or weakenedlimiting the ability of the mitral valve to close adequately against thehigh pressures of the left ventricle. In some cases the mitral valveleaflets detach from the chordae tendinae, the structure that tethersthem to the ventricular wall so that they are positioned to coapt orclose against the other valve leaflet during systole. In this case, theleaflet “flails” or billows into the left atrium during systole insteadof coapting or sealing against the neighboring leaflet allowing bloodfrom the ventricle to surge into the left atrium during systole. Inaddition, mitral valve disease can include functional mitral valvedisease which is usually characterized by the failure of the mitralvalve leaflets to coapt due to an enlarged ventricle, or otherimpediment to the leaflets rising up far enough toward each other toclose the gap or seal against each other during systole.

The most common treatments for mitral valve regurgitation rely on valvereplacement or strengthening of the valve annulus by implanting amechanical support ring or other structure. The latter is generallyreferred to as valve annuloplasty. A recent technique for mitral valverepair which relies on suturing adjacent segments of the opposed valveleaflets together is referred to as the “bow-tie” or “edge-to-edge”technique. While all these techniques can be very effective, theyusually rely on open heart surgery where the patient's chest is opened,typically via a sternotomy, and the patient placed on cardiopulmonarybypass. The need to both open the chest and place the patient on bypassis traumatic and has associated morbidity.

SUMMARY

For the foregoing reasons, it would be desirable to provide alternativeand additional methods, devices, and systems for performing the repairof mitral and other cardiac valves, including the tricuspid valve, whichis the other atrioventricular valve. In some embodiments of the presentinvention, methods and devices may be deployed directly into the heartchambers via a trans-thoracic approach, utilizing a small incision inthe chest wall, or the placement of a cannula or a port. In otherembodiments, such methods, devices, and systems may not require openchest access and be capable of being performed endovascularly, i.e.,using devices which are advanced to the heart from a point in thepatient's vasculature remote from the heart. Still more preferably, themethods, devices, and systems should not require that the heart bebypassed, although the methods, devices, and systems should be usefulwith patients who are bypassed and/or whose heart may be temporarilystopped by drugs or other techniques. At least some of these objectiveswill be met by the inventions described hereinbelow.

In an aspect, disclosed herein is a chordal replacement device having aproximal anchor including a flexible patch and a leaflet attachmentdevice. The flexible patch is affixed to an upper surface of a portionof a flailing leaflet with the leaflet attachment device. The devicealso includes a distal anchor extending and affixed to a distalattachment site in a ventricle; and a flexible tether coupled to andtensioned between the proximal and distal anchors.

In another aspect, there is a chordal replacement device having aproximal anchor including a flexible crimp clip having one or more barbsthat embed into and affix to a portion of a flailing leaflet; a distalanchor extending and affixed to a distal attachment site in a ventricle;and a flexible tether coupled to and tensioned between the proximal anddistal anchors.

The device can include a leaflet attachment device having a pair ofexpandable elements interconnected by a central attachment rod. The pairof expandable elements can sandwich the flexible patch and the leaflet.The leaflet attachment device can include an expandable element. Theexpandable element can be self-deploying and can include a star-shapedbarb, a mesh web, or a mesh ball. The proximal anchor can furtherinclude a mesh stent deployable within an atrium. The mesh stent can becoupled to a flexible rod that extends through a valve commissure intothe ventricle. The distal end of the flexible rod can couple to thedistal anchor and provide consistent tension on the tether during aheart cycle. The flexible rod can have a deflectable, spring-formedshape. The flexible rod can be jointed. The distal anchor and tensionedflexible tether can apply a downward force on the flailing leaflet. Thedistal anchor can include a weight, barb, adhesive, screw, orfluid-filled element. The distal attachment site can include a portionof the ventricle wall, ventricular septum or papillary muscle. Thedistal anchor can fine-tune the tension of the tether after the distalanchor is affixed to the distal attachment site. The distal anchor caninclude a coil screw and wherein rotation of the coil screw fine-tunesthe tension on the tether. The distal anchor can include a balloon andwherein infusion of fluid into the balloon increases tension on thetether.

The flexible tether can have a length that can be adjusted to a desiredtension to apply a downward force on the flailing leaflet. The flexibletether can include one or more loops of a flexible material. The one ormore loops can be drawn together at a distal end region with an enclosedelement. The enclosed element can couple the one or more loops to thedistal anchor. The one or more loops can be coupled to the proximal anddistal anchors such that the one or more loops self-equalize and evenlydistribute tension on the flailing leaflets and on distal attachmentsite.

In another aspect, disclosed is a chordal replacement device including aproximal anchor comprising a flexible crimp clip having one or morebarbs that embed into and affix to a portion of a flailing leaflet; adistal anchor extending and affixed to a distal attachment site in aventricle; and a flexible tether coupled to and tensioned between theproximal and distal anchors.

The distal anchor and flexible tether can hold down the flailingleaflet. The distal anchor can include a weight, barb, adhesive, screw,or fluid-filled element. The distal attachment site can include aportion of the ventricle wall, ventricular septum or papillary muscle.The distal anchor can fine-tune the tension of the tether after thedistal anchor is affixed to the distal attachment site. The distalanchor can include a coil screw and wherein rotation of the coil screwfine-tunes the tension on the tether. The distal anchor can include aballoon and wherein infusion of fluid into the balloon increases tensionon the tether. The tether can have a length that can be adjusted to adesired tension to hold the leaflet down.

In another aspect, disclosed is a method for repairing a cardiac valveincluding accessing a patient's vasculature remote from the heart;advancing an interventional tool through an access sheath to a locationnear the cardiac valve, the interventional tool comprising a distalflange; affixing a chordal replacement device to a portion of a flailingleaflet, the chordal replacement device including a flexible patch; oneor more leaflet attachment devices; a distal anchor; and a flexibletether coupled to and tensioned between the flexible patch and thedistal anchor. The method also includes coupling the distal anchor to adistal attachment site in a ventricle; and applying a downward force onthe flailing leaflet with the tether and distal anchor so as to preventflail of the leaflet into the atrium.

Affixing a chordal replacement device can further include positioningthe flexible patch on an upper surface of a flailing leaflet, piercingthe patch and the leaflet with the one or more leaflet attachmentdevices, and sandwiching the leaflet and the patch between a pair ofexpandable elements. The pair of expandable elements can beself-deploying. The distal anchor can include a weight, barb, adhesive,coil screw or fluid-filled element. The distal attachment site caninclude a portion of the ventricle wall, ventricular septum or papillarymuscle. The method can further include observing flow through thecardiac valve to determine if leaflet flail, valve prolapse or valveregurgitation are inhibited. The method can further include adjustingtension of the tether coupled to and tensioned between the flexiblepatch and the distal anchor. The distal anchor can include a coil screwand wherein adjusting the tension of the tether comprises rotating thecoil screw. The distal anchor can include a balloon and whereinadjusting the tension of the tether comprises infusing fluid into theballoon. The method can further include sensing contact between thedistal anchor and the distal attachment site.

Other features and advantages should be apparent from the followingdescription of various embodiments, which illustrate, by way of example,the principles of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic illustration of the left ventricle of a heartshowing blood flow during systole with arrows.

FIG. 1B shows a cross-sectional view of the heart wherein a flexiblestent is positioned at or near the mitral valve.

FIG. 2A shows a cross-sectional view of the heart showing one or moremagnets positioned around the annulus of the mitral valve.

FIG. 2B shows an annular band with magnets that can be positioned on themitral valve annulus.

FIG. 3 shows a cross-sectional view of the heart identifying locationsfor placement of valves.

FIG. 4 show a cross-sectional view of the heart with a pair of flapsmounted at or near the mitral valve.

FIG. 5A shows a schematic side view of the mitral valve leaflets with aflap positioned immediately below each leaflet.

FIG. 5B shows a downward view of the mitral valve with a pair ofexemplary flaps superimposed over the leaflets.

FIG. 5C shows a pair of mitral valve leaflet flaps having complementaryshapes.

FIG. 6A shows a cross-sectional view of the heart with a membrane ringpositioned at the mitral valve annulus.

FIG. 6B shows a schematic view of the membrane ring, which includes anannular ring on which is mounted a membrane.

FIG. 7A shows a cross-sectional view of a heart with a bladder devicepositioned partially within the left ventricle and partially within theleft atrium.

FIG. 7B shows a schematic side view of the mitral valve leaflets failingto coapt.

FIG. 7C shows a schematic side view of the mitral valve leaflets with abladder positioned between the leaflets.

FIG. 7D shows a plan view of the mitral valve with the leaflets in anabnormal closure state such that a gap is present between the leaflets.

FIG. 8 shows a cross-sectional view of the heart wherein a one-way valvedevice is located in the left atrium.

FIG. 9A shows a prosthetic ring that is sized to fit within a mitralvalve.

FIG. 9B shows another embodiment of a prosthetic ring wherein a one-wayvalve is positioned inside the ring.

FIG. 10 shows a prosthetic with one or more tongues or flaps that areconfigured to be positioned adjacent the flaps of the mitral valve.

FIG. 11A shows an exemplary embodiment of one or more clips that arepositioned on free edges of the leaflets.

FIG. 11B shows pair of leaflets with a magnetic clip attached to theunderside of each leaflet.

FIG. 11C shows the leaflets coapted as a result of the magneticattraction between the magnetic clips.

FIG. 11D shows a pair of leaflets with a single clip attached to one ofthe leaflets.

FIG. 12 shows a schematic, cross-sectional view of the heart with awedge positioned below at least one of the leaflets of the mitral valve.

FIG. 13A shows an artificial chordae tendon.

FIGS. 13B and 13C show attachment devices for attaching the artificialchordae tendon to a heart wall.

FIG. 14 shows a cross-sectional view of the heart with a first andsecond anchor attached to a wall of the heart.

FIG. 15 shows a catheter that has been introduced into the heart.

FIG. 16 shows a schematic view of a papillary muscle with a ringpositioned over the muscle.

FIG. 17 shows a cross-sectional view of the heart with one or moremagnets attached to a wall of the left ventricle.

FIG. 18A shows another embodiment of a procedure wherein magnets areimplanted in the heart to geometrically reshape the annulus or the leftventricle.

FIG. 18B shows the heart wherein tethered magnets are implanted invarious locations to geometrically reshape the annulus or the leftventricle.

FIG. 18C shows the heart wherein magnets are implanted in variouslocations to geometrically reshape the annulus or the left ventricle.

FIG. 19 shows another embodiment of a procedure wherein magnets areimplanted in the heart to geometrically reshape the annulus or the leftventricle.

FIG. 20 shows a cross-sectional view of the left ventricle with a tetherpositioned therein.

FIG. 21 shows a cross-sectional view of the left ventricle with adelivery catheter positioned therein.

FIG. 22 shows a cross-sectional view of the left ventricle with thedelivery catheter penetrating a wall of the left ventricle.

FIG. 23 shows a cross-sectional view of the left ventricle with thedelivery catheter delivering a patch to the wall of the left ventricle.

FIG. 24 shows a cross-sectional view of the left ventricle with thedelivery penetrating delivering a second patch.

FIG. 25 shows a cross-sectional view of the left ventricle with twotethers attached together at opposite ends from the patches mounted inthe heart.

FIG. 26 shows a cross-sectional view of the left ventricle with a needleor delivery catheter passed transthoracically into the left ventricle LVto deliver a patch to the exterior of the ventricular wall.

FIG. 27 shows a schematic, cross-sectional view of the left ventricle ina healthy state with the mitral valve closed.

FIG. 28 shows the left ventricle in a dysfunctional state.

FIG. 29 shows the left ventricle with a biasing member mounted betweenthe papillary muscles.

FIG. 30 shows the left ventricle with a suture mounted between thepapillary muscles.

FIG. 31 shows the left ventricle with a snare positioned around thechordae at or near the location where the chordae attach with thepapillary muscles.

FIG. 32 shows a leaflet grasping device that is configured to grasp andsecure the leaflets of the mitral valve.

FIGS. 33A-33C show the leaflet grasping device grasping leaflets of themitral valve.

FIG. 34 shows the left ventricle with a needle being advanced from theleft atrium into the left ventricle via the leaflet grasping device.

FIG. 35 shows the left ventricle with sutures holding the papillarymuscles in a desired position.

FIG. 36 shows a cross-sectional view of the heart with one or more clipsclipped to each of the papillary muscles.

FIG. 37 shows a cross-sectional view of the heart with tethered clipsattached to opposed walls of the left ventricle.

FIGS. 38A-38C show an embodiment of a chordal replacement device.

FIGS. 39A-39M show another embodiment of a chordal replacement device.

FIGS. 39N-39O show an embodiment of a dual function clamp and deploymentof an embodiment of a chordal replacement device.

FIGS. 40A-40B show another embodiment of a chordal replacement device.

FIGS. 41A-41B show a cross-sectional view of the chordal replacementdevice of FIGS. 40A-40B being deployed.

FIGS. 41C-41E show an embodiment of an attachment device fixing achordal replacement device to a valve leaflet.

FIG. 41F shows an embodiment of an expandable feature of an attachmentdevice having a star-shaped design.

FIGS. 41G-41P show embodiments of a leaflet stabilizing mechanism.

FIGS. 42A-42D show various embodiments of an expandable feature of anattachment device.

FIGS. 43A-43B show an embodiment of attachment devices fixing a patch toa valve leaflet.

FIGS. 44A-44D show various steps in the deployment of an embodiment of achordal replacement device.

FIGS. 45A-45D show various embodiments of a distal attachment assemblydeployed in the ventricle wall.

FIGS. 46A-46B show an embodiment of a sensor used in the adjustment ofartificial chordae tension.

FIG. 47 illustrates an embodiment of fine-tuning the tension on theartificial chordae.

FIGS. 48A-48B illustrate another embodiment of fine-tuning the tensionon the artificial chordae.

FIGS. 49A-49B show another embodiment of an attachment assembly for achordal replacement device.

FIGS. 50A-50B show another embodiment of an attachment assembly for achordal replacement device.

FIGS. 50C-50E show an embodiment of a jointed rod having mechanicallocking feature.

FIG. 50F illustrates the independent pivot axes of a jointed rod system.

FIGS. 51A-51B show another embodiment of an attachment assembly for achordal replacement device.

FIGS. 52A-52C show an embodiment of a leaflet extension device blockingvalve leaflet flail.

DETAILED DESCRIPTION

The present invention provides methods, systems, and devices for theendovascular repair of cardiac valves, particularly the atrioventricularvalves which inhibit back flow of blood from a heart ventricle duringcontraction (systole), most particularly the mitral valve between theleft atrium and the left ventricle. By “endovascular,” it is meant thatthe procedure(s) of the present invention are performed withinterventional tools, guides and supporting catheters and otherequipment introduced to the heart chambers from the patient's arterialor venous vasculature remote from the heart. The interventional toolsand other equipment may be introduced percutaneously, i.e., through anaccess sheath, or may be introduced via a surgical cut down, and thenadvanced from the remote access site through the vasculature until theyreach the heart. Thus, the procedures of the present invention willgenerally not require penetrations made directly through the exteriorheart muscle, i.e., myocardium, although there may be some instanceswhere penetrations will be made interior to the heart, e.g., through theinteratrial septum to provide for a desired access route.

While the procedures of the present invention will usually bepercutaneous and intravascular, many of the tools will find use inminimally invasive and open surgical procedures as well that includes asurgical incision or port access through the heart wall. In particular,the tools for capturing the valve leaflets prior to attachment can finduse in virtually any type of procedure for modifying cardiac valvefunction.

The atrioventricular valves are located at the junctions of the atriaand their respective ventricles. The atrioventricular valve between theright atrium and the right ventricle has three valve leaflets (cusps)and is referred to as the tricuspid or right atrioventricular valve. Theatrioventricular valve between the left atrium and the left ventricle isa bicuspid valve having only two leaflets (cusps) and is generallyreferred to as the mitral valve. In both cases, the valve leaflets areconnected to the base of the atrial chamber in a region referred to asthe valve annulus, and the valve leaflets extend generally downwardlyfrom the annulus into the associated ventricle. In this way, the valveleaflets open during diastole when the heart atria fill with blood,allowing the blood to pass into the ventricle.

During systole, however, the valve leaflets are pushed together andclosed to prevent back flow of blood into the atria. The lower ends ofthe valve leaflets are connected through tendon-like tissue structurescalled the chordae, which in turn are connected at their lower ends tothe papillary muscles. Interventions according to the present inventionmay be directed at any one of the leaflets, chordae, annulus, orpapillary muscles, or combinations thereof. It will be the generalpurpose of such interventions to modify the manner in which the valveleaflets coapt or close during systole so that back flow orregurgitation is minimized or prevented.

The left ventricle LV of a normal heart H in systole is illustrated inFIG. 1A. The left ventricle LV is contracting and blood flows outwardlythrough the tricuspid (aortic) valve AV in the direction of the arrows.Back flow of blood or “regurgitation” through the mitral valve MV isprevented since the mitral valve is configured as a “check valve” whichprevents back flow when pressure in the left ventricle is higher thanthat in the left atrium LA. The mitral valve MV comprises a pair ofleaflets having free edges FE which meet evenly to close, as illustratedin FIG. 1A. The opposite ends of the leaflets LF are attached to thesurrounding heart structure along an annular region referred to as theannulus AN. The free edges FE of the leaflets LF are secured to thelower portions of the left ventricle LV through chordae tendineae CT(referred to hereinafter as the chordae) which include plurality ofbranching tendons secured over the lower surfaces of each of the valveleaflets LF. The chordae CT in turn, are attached to the papillarymuscles PM which extend upwardly from the lower portions of the leftventricle and interventricular septum IVS.

While the procedures of the present invention will be most useful withthe atrioventricular valves, at least some of the tools describedhereinafter may be useful in the repair of other cardiac valves, such asperipheral valves or valves on the venous side of the cardiaccirculation, or the aortic valve.

The methods of the present invention can comprise accessing a patient'svasculature at a location remote from the heart, advancing aninterventional tool through the vasculature to a ventricle and/oratrium, and engaging the tool against a tissue structure which forms orsupports the atrioventricular valve. By engaging the tool against thetissue structure, the tissue structure is modified in a manner thatreduces valve leakage or regurgitation during ventricular systole. Thetissue structure may be any of one or more of the group consisting ofthe valve leaflets, chordae, the valve annulus, and the papillarymuscles, atrial wall, ventricular wall or adjacent structures.Optionally, the interventional tool will be oriented relative to theatrioventricular valve and/or tissue structure prior to engaging thetool against the tissue structure. The interventional tool may beself-orienting (e.g., pre-shaped) or may include active mechanisms tosteer, adjust, or otherwise position the tool.

Alternatively, orientation of the interventional tool may beaccomplished in whole or in part using a separate guide catheter, wherethe guide catheter may be pre-shaped and/or include active steering orother positioning means such as those devices set forth in United StatesPatent Publication Numbers 2004/0044350, 2004/0092962, and 2004/0087975,all of which are expressly incorporated by reference herein. In allcases, it will usually be desirable to confirm the position prior toengaging the valve leaflets or other tissue structures. Such orientingstep may comprise positioning the tool relative to a line of coaptationin the atrioventricular valve, e.g., engaging positioning elements inthe valve commissures and confirming the desired location using avariety of imaging means such as magnetic resonant imaging (MRI),intracardiac echocardiography (ICE), transesophageal echo (TEE),fluoroscopy, endoscopy, intravascular ultrasound (IVUS) and the like.

In some embodiments, heart disease in general, and valve repair inparticular, are treated by targeting the pacing of the heartbeat. In oneembodiment, heart disease is treated by introducing one or more pacingleads into a heart chamber. The pacing leads are placed in contact witha heart muscle and are in electrical communication with a power source.The power source provides paced electrical stimuli to the heart muscle.The electrical stimuli are provided during or immediately after systoleto extend systolic contraction of the heart, thereby extending the rangeof systole during each heartbeat. This extension of systole extends theamount of time in which the heart muscle tightens when it wouldotherwise be relaxing, when there is most mitral regurgitation indiseased mitral valves.

Other embodiments are directed to annuloplasty to treat heart disease ingeneral and valve repair in particular. In one embodiment, showngenerally in FIG. 1B, a stent is used to treat the mitral valve. FIG. 1Bshows a cross-sectional view of the heart wherein a flexible stent 100is positioned at or near the mitral valve MV. The stent 100 is annularand is sized and shaped to be positioned on the annulus of the mitralvalve. The stent 100 can transition between a collapsed state of reducedsize and an expanded state of enlarged size relative to the collapsedstate.

The flexible stent 100 can be percutaneously introduced into anindividual's heart while being biased toward the collapsed state. Thestent is advanced partially through the annulus of the mitral valve sothat it is coaxially positioned within the annulus, as shown in FIG. 1B.The stent 100 is then secured to the annulus such that the stent exertsan inward force on the annulus thereby causing the annulus to resistdilation during diastole of the heart.

In yet another embodiment, a device is disclosed for treating the mitralvalve. The device can be a stent, such as the stent 100, that is sizedto fit coaxially within an annulus of a mitral valve. The stent includesa hollow frame. The frame can be annular such that it has across-sectional diameter that is sized such that an outer surface of theframe is in continuous coaxial contact with the annulus. The frame alsoincludes one or more anchors protruding from it for securing the stentto the annulus. The anchors can be prongs, barbs, protrusions, or anystructure adapted to secure the stent to the annulus. The stent isflexible between an expanded configuration and a contractedconfiguration and is biased toward the contracted configuration so thatit exerts an inward force on the annulus.

In one embodiment, the stent 100 is delivered using a delivery catheter10 that is advanced from the inferior vena cava IVC into the rightatrium RA. Once the catheter 10 reaches the anterior side of theinteratrial septum IAS, a needle 12 may be advanced so that itpenetrates through the septum at the fossa ovalis FO or the foramenovale into the left atrium LA. At this point, a delivery device can beexchanged for the needle and the delivery device used to deliver thestent 100. The catheter 10 can also approach the heart in other manners.

FIG. 2A shows a cross-sectional view of the heart showing one or moremagnets 205 positioned around the annulus of the mitral valve MV. Acorresponding method of treating heart disease involves the use ofmagnets. The method includes percutaneously introducing at least a firstmagnet 205 into an individual's heart and securing it to the mitralvalve MV annulus. At least a second magnet 205 is percutaneouslyintroduced into the heart and advanced so that it is within a magneticfield of the first magnet. The second magnet is secured to the heart.The polarity of one of the two magnets is then cyclically changed insynchronization with the heart beat so that the magnets attract andrepel each other in synchronization with the heart beat. The firstmagnet therefore moves in relation to the second magnet and exerts aninward closing force on the mitral valve during systole. The magnets 205can be positioned on an annular band 215 (shown in FIG. 2B) that issized and shaped to be implanted on the annulus of the mitral valve. Theband 215 can be, for example, a stent.

In one embodiment, the magnets 205 or the annular band 215 are deliveredusing a delivery catheter 10 that is advanced from the inferior venacava IVC into the right atrium RA, as described above with reference toFIG. 1. Any of the devices described herein can be percutaneouslydelivered into the heart by coupling the device to a delivery device,such as a steerable delivery catheter.

In yet another embodiment involving magnets, two or more magnets arepercutaneously introduced into an individual's coronary sinus such thatthey attract or repel each other to reshape the coronary sinus and anunderlying mitral valve annulus.

Other embodiments involve various prosthetics for treating heart diseasein general and defective or diseased mitral valves in particular. In oneembodiment, a method of treatment includes placing one or more one-wayvalves in one or more pulmonary veins of an individual either near theostium of the vein or at some point along the length of the PV. Valvesthat may be used, for example may be stentless valves such as designssimilar to the TORONTO SPV® (Stentless Porcine Valve) valve, mechanicalor tissue heart valves or percutaneous heart valves as are known in theart provided they are sized appropriately to fit within the lumen of thepulmonary vein, as shown in FIG. 3. In FIG. 3, the locations in the leftatrium LA where valves can be positioned in pulmonary vein orifices arerepresented by an “X”. In addition, certain venous valve devices andtechniques may be employed such as those described in U.S. Pat. Nos.6,299,637 and 6,585,761, and United States Patent Publication Numbers2004/0215339 and 2005/0273160, the entire contents of which areincorporated herein by reference. A valve prosthesis for placement inthe ostia of the pulmonary vein from the left atrium may be in the rangeof 6-20 mm in diameter. Placement of individual valves in the pulmonaryvein ostia (where the pulmonary veins open or take off from the leftatrium) may be achieved by obtaining trans septal access to the leftatrium with a steerable catheter, positioning a guidewire through thecatheter and into the targeted pulmonary vein, and deploying a valvedelivery catheter over the guidewire and deploying the valve out of thedelivery catheter. The valve may be formed of a deformable material,such as stainless steel, or of a self-expanding material such as NiTi,and include tissue leaflets or leaflets formed of a synthetic material,such as is known in the art. A line of +++++ symbols in FIG. 3represents a mid-atrial location above the mitral valve where a singlevalve can be positioned as disclosed later in this specification.

The following references, all of which are expressly incorporated byreference herein, describe devices (such as steerable catheters) andmethods for delivering interventional devices to a target locationwithin a body: United States Patent Publication Numbers 2004/0044350,2004/0092962 and 2004/0087975.

FIG. 4 show a cross-sectional view of the heart with a pair of flapsmounted at or near the mitral valve. FIG. 5A shows a schematic side viewof the mitral valve leaflets LF with a flap 300 positioned immediatelybelow each leaflet. The flap 300 can be contoured so as to conform atleast approximately to the shape of a leaflet, or the flap 300 can bestraight as shown in FIG. 4. FIG. 5B shows a downward view of the mitralvalve with a pair of exemplary flaps superimposed over the leaflets LF.As shown in FIG. 5C, the flaps can have complementary shapes with afirst flap having a protrusion that mates with a corresponding recess ina second flap.

In corresponding method of treatment, shown in FIGS. 4 and 5C, a firstflap 300 with an attachment end 305 and a free end 310 is provided. Theattachment end 305 of the first flap 300 is secured to the inside wallof the ventricle below the mitral valve. A second flap 315 with anattachment end 320 and a free end 330 is provided and is also secured tothe inside wall of the ventricle below the mitral valve. The first andsecond flaps 300, 315 are oriented so that they face each other and thefree ends 310, 330 are biased toward each other and approximate againsteach other during systole. This system provides a redundant valvingsystem to assist the function of the native mitral valve.

In other embodiments, devices and methods that involve prosthetic discsare disclosed. For example, FIG. 6A shows a cross-sectional view of theheart with a membrane ring 610 positioned at the mitral valve annulus.FIG. 6B shows a schematic view of the membrane ring 610, which includesan annular ring on which is mounted a membrane. The membrane includes aseries of perforations 615 extending through the membrane surface. Oneor more anchor devices, such as prongs, can be located on the ring forsecuring the ring to the mitral valve.

In one embodiment, a device for treating heart disease in general anddefective or diseased mitral valves in particular includes a disc havinga ring, a membrane stretched across an opening of the ring, and one ormore anchors for securing the disc to an annulus of a mitral valve. Thedisc is sized to cover the annulus of the mitral valve, and the membraneincludes one or more perforations that permit one way fluid flow throughthe disc. Methods of treatment using the device are also provided.

In other embodiments, devices and methods that involve fluid-filledbladders are disclosed. FIG. 7A shows a cross-sectional view of a heartwith a bladder device positioned partially within the left ventricle andpartially within the left atrium. A device for treating heart disease ingeneral and defective or diseased mitral valves in particular includes afluid-filled bladder 600. The bladder 600 is placed across the mitralvalve between the left atrium and the left ventricle. Upon compressionof the left ventricle, the volume of the bladder is expanded on the leftatrial side of the heart, providing a baffle or sealing volume to whichthe leaflets of the mitral valve coapt. The bladder may also act as ablocking device in the case of flail of a leaflet, blocking saidflailing leaflet from billowing into the left atrium causingregurgitation. The bladder also includes one or more anchors forsecuring the bladder to an annulus of a mitral valve, or may be formedon a cage or other infrastructure to position it within the line ofcoaptation of the mitral valve.

A bladder can also be used to treat functional mitral valve disease. Asmentioned, functional mitral valve disease is usually characterized bythe failure of the mitral valve leaflets to coapt due to an enlargedventricle, or other impediment to the leaflets rising up far enoughtoward each other to close the gap or seal against each other duringsystole. FIG. 7B shows a schematic side view of the mitral valveleaflets LF failing to coapt such that regurgitation can occur (asrepresented by the arrow RF.) With reference to FIG. 7C, a baffle orbladder 630 is positioned between the leaflets LF along the line ofcoaptation of the leaflets. The bladder 630 provides a surface againstwhich at least a portion of the leaflets LF can seal against. Thebladder 630 thus serves as a coaptation device for the leaflets. Thebladder can be attached to various locations adjacent to or on themitral valve. FIG. 7D shows a plan view of the mitral valve with theleaflets LF in an abnormal closure state such that a gap G is presentbetween the leaflets. In one embodiment, the bladder is attached oranchored to the mitral valve at opposite edges E of the gap G.

Methods of treatment using the bladder include providing the bladder andinserting it through an annulus of a mitral valve such that the bladderis coaxially positioned through the mitral valve. An atrial portion ofthe bladder extends into the left atrium, and a ventricular portion ofthe bladder extends into the left ventricle. A mid portion of thebladder may be secured to the annulus of the mitral valve such that themid portion remains stationery while the atrial and ventricular portionsexpand and contract passively between the atrium and ventricle based onpressure differentials during systole and diastole.

FIG. 8 shows a cross-sectional view of the heart wherein a one-way valvedevice 700 is located in the left atrium. The valve device isrepresented schematically in FIG. 8. A corresponding method of treatingheart disease includes introducing a one-way valve device 700 into theleft atrium of an individual's heart proximal the mitral valve. Thevalve device 700 is configured to permit fluid flow in one directionwhile preventing fluid flow in an opposite direction. The valve devicecan have various structures. For example, the device can comprise avalve that is mounted on a stent that is sized to be positioned in theleft atrium. Valves that may be used, for example may be stentlessvalves such as the TORONTO SPV® (Stentless Porcine Valve) valve,mechanical or tissue heart valves or percutaneous heart valves as areknown in the art. The outer wall of the one-way valve device is sealedto the inner wall of the atrium so that a fluid-tight seal is formedbetween the outer wall of the one-way valve device and the inner wall ofthe left atrium. In this regard, the valve device can include a sealmember that is configured to seal to the inner wall of the atrium.

Another embodiment involves a prosthetic for treating heart disease ingeneral and defective or diseased mitral valves in particular. FIG. 9Ashows a prosthetic ring 800 that is sized to fit within a mitral valveannulus The ring includes one or more anchors 805 that extend around theperiphery of the ring 800. In addition, one or more struts 810 strutsextend across the diameter of the ring, and can be made of a materialthat includes Nitinol or magnetic wires for selectively adjusting theshape of the ring. The struts can also be instrumental in bafflingmitral valve leaflet “flail”. FIG. 9B shows another embodiment of aprosthetic ring 807 wherein a one-way valve 815 is positioned inside thering such that blood flow BF can flow through the valve in only onedirection. The valve can be manufactured of various materials, such assilicone.

FIG. 10 shows a prosthetic with one or more tongues or flaps that areconfigured to be positioned adjacent the flaps of the mitral valve. Theprosthetic includes a ring 900 sized to fit within a mitral valveannulus. At least two tongues 910 project from the ring 900 in a caudaldirection when the ring is implanted into a heart of an individual. Thering is flexible between an expanded configuration and a contractedconfiguration and is biased toward the contracted configuration. One ormore anchors 920 protrude from the flexible ring for coupling the ringcoaxially to the annulus such that the contracted configuration of thering exerts an inward force to the annulus. Alternatively, or inaddition, the two tongues can each have a length sufficient to preventprolapse of a mitral valve when the ring is placed atop the leaflets ofthe mitral valve. In a further embodiment the tongue elements may beattached at a central point.

In yet another embodiment, a prosthetic for treating heart disease ingeneral and a defective or diseased mitral valve in particular includesa wedge. The wedge has a length that is about equal to a length of theline of coaptation of a mitral valve. The wedge has a depth sufficientto prevent prolapse of a mitral valve when the wedge is placed atop anannulus of the mitral valve along the line of coaptation, and mayprovide a point of coaptation for each leaflet. One or more anchorsprotrude from the wedge for coupling the wedge to the annulus of themitral valve. Methods of treatment using the wedge are also disclosed.The methods include inserting the wedge into an individual's heart,placing the wedge lengthwise along the line of coaptation of the mitralvalve. The wedge is then secured to an annulus of the mitral valve alongthe line of coaptation. The wedge may be positioned also just under onesegment of the leaflet (likely P2 in the case of functional MR).

In yet another embodiment, a device for treating heart disease includesa clip for attachment to a free end of a heart valve leaflet. FIG. 11Ashows an exemplary embodiment of one or more clips 1101 that arepositioned on free edges of the leaflets LF. Each of the clips 1101 hasa shape that prevents flail of the leaflet by catching against anunderside of an opposing leaflet. Methods of treatment using the clipare also disclosed. The methods include introducing the clip into anindividual's heart and attaching the clip to a free end of a heart valveleaflet opposite the free end of an opposing leaflet of the heart valveso that the clip catches to the underside of the opposing leaflet duringsystole. In a further embodiment, a clip may be placed on both leafletssuch that the clips meet or catch when the leaflets are in proximity.The clips may attach momentarily during systole, and then detach duringdiastole, or may clip permanently resulting in a double orifice mitralvalve anatomy. The clips of this embodiment may include a magneticelement, or one may be magnetic and the other of a metal materialattracted to said electromagnetic field of the magnetic clip.

In the case of magnetic clips, the clip elements may be placed on theunderside of the leaflets (e.g. not necessarily on the free edge of theleaflet), provided that the magnetic field of the clip is sufficient toattract the opposing magnetic or metal clip element. This is furtherdescribed with reference to FIG. 11B, which shows pair of leaflets LFwith a clip 1101 attached to the underside of each leaflet. At least oneof the clips is magnetic, while the other clip is of an oppositemagnetic polarity than the first clip or of a metal attracted to themagnetic field of the first clip. The magnetic field is sufficientlystrong such that the clips 1101 can attach to one another eithermomentarily or permanently to coapt the leaflets, as shown in FIG. 11C.

In another embodiment, shown in FIG. 11D, a single clip 1101 is attachedto one of the leaflets. The clip 1101 is sufficiently long to increasethe likelihood that the clip 1101 will coapt with the opposite leaflet.

In yet another embodiment, a device for treating heart disease includesa wedge for placement under a heart valve leaflet. FIG. 12 shows aschematic, cross-sectional view of the heart with a wedge 1205positioned below at least one of the leaflets of the mitral valve. Thewedge 1205 can be positioned below one or both of the leaflets. Thewedge 1205 is sized to fit under the valve leaflet and caudal theannulus of the heart valve. The wedge 1205 can have a shape that iscontoured so as to provide support to a lower surface of the leaflet.(In FIG. 12, the left atrium is labeled LA and the left ventricle islabeled LV.) An anchor is attached to the wedge for coupling the wedgeto a wall of the heart chamber adjacent the heart valve. The wedge formsa fixed backstop against the bottom side of the heart valve leaflet,thereby providing a location for the leaflet to coapt against, and/orproviding support or “pushing up” a restricted leaflet.

Other embodiments are directed to altering the size, shape, chemistry,stiffness, or other physical attributes of heart valve leaflets. In oneembodiment in particular, a method of treating heart disease includesobtaining access to a heart valve leaflet and injecting a stiffeningagent into the leaflet to stiffen the leaflet and minimize flail.

Other embodiments are directed to the chordae that connect heart valveleaflets to the inner walls of the heart. In one embodiment inparticular, a method of treating heart disease includes obtaining accessto a heart valve chord and cutting it mechanically or with energy suchas a laser, or by heating the chordae to elongate them, thereby allowingthe previously restricted leaflet to be less restricted so that it cancoapt with the opposing leaflet.

In another embodiment directed to the chordae that connect heart valveleaflets to the inner walls of the heart, a cam-shaped ring isdisclosed. The cam-shaped ring is sized to fit within a left ventricleof a heart. The ring forms a hole that is sized to receive two or morechordae tendineae. The ring is formed by connecting two detachable endsof the ring.

Methods of treatment using the cam-shaped ring are also disclosed. Onemethod in particular includes introducing the ring into a left ventricleof a heart. One or more chordae tendineae are then surrounded by thering, and the two ends of the ring are then attached to form a closedring around the chordae tendineae. The ring is then rotated such thatone or more of the chordae tendineae are shifted away from their initialorientation by the rotation of the cam-shaped ring. The ring may then befixed in the rotated or tightened position.

An embodiment directed at the chordae of heart valve leaflets is nowdescribed. FIG. 13A shows a device that can be used to alter a chordae.A method includes obtaining access to a chordae tendinea (chord) withinan individual's heart chamber. The chordae is then cut at a point alongits length so that a length of the chordae tendinea is freed from theheart chamber leaving behind a length of chordae tendinea having a freeend and an end attached to an edge of a heart valve.

With reference to FIG. 13A, a synthetic chord 1005 of greater lengththan the free length of chordae is introduced into the heart chamber.One end of the synthetic chordae 1005 is connected to a wall 1305 of theheart chamber or to a muscle attached to the wall of the heart chamber.Another end of the synthetic chord is attached to the free end of thechorda tendinea or to the leaflet.

In this regard, the end of the chord 1005 that is attached the wall 1305can have any of a variety of devices that facilitate such attachment.FIGS. 13B and 13C show enlarged views of attachment devices containedwithin box 13 of FIG. 13A. The attachment devices can be used to attachthe chord 1005 to the wall 1305. In FIG. 13B, the attachment device 1310is an enlarged ball having a distal trocar for penetrating the wall1305. In FIG. 13C, the attachment device 1310 is a hook that isconfigured to penetrate through the wall 1305. It should be appreciatedthat the attachment device 1310 can have other structures and it notlimited to the structures shown in FIGS. 13B and 13C. In variations ofthese embodiments, it may be advantageous to adjust the length of thechordae (synthetic, or modified), determine the therapeutic effect ofthe shortening or lengthening, and then fix the chordae at the mostefficacious location.

Valve regurgitation due to flail or broken chordae can occur. Such valveimpairments can be treated percutaneously through chordal replacement orthe supplementing of the chordae tendineae of the mitral valve. Althoughthe embodiments described herein are with reference to treating mitralvalve impairments it should be appreciated that other valves couldsimilarly be treated with the embodiments described herein. Theconfiguration of the chordal replacement devices described herein canvary. Features of the various devices and their anchoring systems can beused in combination with any of the embodiments described herein.

The chordal replacement devices described herein can be delivered usinginterventional tools, guides and supporting catheters and otherequipment introduced to the heart chambers from the patient's arterialor venous vasculature remote from the heart. The chordal replacementdevices described herein can be compressed to a low profile forminimally-invasive or percutaneous delivery. They can be advanced fromthe remote access site through the vasculature until they reach theheart. For example, the chordal replacement devices can be advanced froma venous site such as the femoral vein, jugular vein, or another portionof the patient's vasculature. It is also appreciated that chordalreplacement devices can be inserted directly into the body through achest incision. A guidewire can be steered from a remote site throughthe patient's vasculature into the inferior vena cava (IVC) through theright atrium so that the guidewire pierces the interatrial septum. Theguidewire can then extend across the left atrium and then downwardthrough the mitral valve MV to the left ventricle. After the guidewireis appropriately positioned, a catheter can be passed over the guidewireand used for delivery of a chordal replacement device.

Embodiments of the chordal replacement devices described herein can alsobe delivered using a catheter advanced through retrograde accessthrough, for example an artery, across the aortic arch and the aorticvalve and to the mitral valve by way of the ventricle. Alternativedelivery methods of chordal replacement device embodiments describedherein can include inserting the device through a small access port suchas a mini-thoracotomy in the chest wall and into the left ventricleapex. From there, the chordal replacement device can be advanced throughthe left ventricle into the left atrium. It should be appreciated thedevice can also be delivered via the left atrial apex as well.Positioning of the tool and/or chordal replacement devices describedherein can be confirmed using a variety of imaging means such asmagnetic resonant imaging (MRI), intracardiac echocardiography (ICE),transesophageal echo (TEE), fluoroscopy, endoscopy, intravascularultrasound (IVUS) and the like.

In an embodiment and as shown in FIGS. 38A-38C, a chordal replacementdevice 3805 can include a laterally-stabilized spring or flexible rod.In one embodiment, the device 3805 can include a first portion 3810 thatreceives and/or is movable with respect to a second portion 3815. Thefirst and second portions 3810, 3815 can be surrounded by a spring 3820.Each of the first and second portions 3810, 3815 of the device 3805 canhave a platform region 3825, 3830, respectively between which the spring3820 extends. The platform regions 3825, 3830 can be of sufficientsurface area or diameter that they can push against the heart wall andthe leaflet surface without damaging or puncturing the surfaces. In anembodiment, the platform regions 3825, 3830 can also each have one ormore barbs 3835 or another fixation device on an external surface thatcan implant and attach the device 3805 between the valve leaflet and theroof of the atrium (see FIG. 38C). It should also be appreciated thatother attachment mechanisms for attaching one or more of the platformsections to the valve leaflet and/or the roof of the atrium are possibleand that the device is not limited to including barbs. For example, oneor more of the platforms can include clips such as a clip similar to theMitraclip® to grasp the leaflet, and an adhesive or screw to attach tothe roof of the atrium.

The chordal replacement device 3805 can be delivered into the leftatrium through a guide catheter 3840 (see FIG. 38B). A tether 3845 canhold the device 3805 normal to the tip of the guide catheter 3840. Thetether 3845 can be threaded through the guide catheter 3840, through theimplant 3805, and back out the guide catheter 3840. When the procedureis completed, the tether 3845 can be pulled out of the guide catheter3840 from either end releasing the implant, allowing deployment. Othermechanisms of attachment to the implant 3805 are considered herein. Forexample, the tether 3845 can be replaced by a flexible rod having, forexample threads at a distal end. The threads of the rod can attach tocorresponding threads on the implant 3805. The threaded region of theimplant can be rotatable such that the implant 3805 can rotateperpendicular to the guide catheter 3840 (see the position shown in FIG.38B) in order to couple and uncouple with the rod through rotationalthreading and unthreading.

As shown in FIG. 38B, a second tether 3850 can be used to longitudinallycompress the spring 3820 between the platforms 3825, 3830 such that theyapproximate one another and the first portion 3810 receives a greaterlength of the second portion 3815 than it receives in the uncompressedstate and the overall length of the device 3805 is reduced as defined bythe distance between the barbs. This second tether 3850 can threadthrough the guide catheter 3840 in a similar manner as the first tether3845 as described above. The second tether 3850 can be tensioned tocompress the spring 3820 and after removal can be withdrawn similarly asthe first tether 3845. In an embodiment, a barb 3835 can be planted intoa portion of the flailing valve leaflet and another barb 3835 can beplanted into the roof of the left atrium LA. The barbs can be planted byactuating the distal curved section of the guide catheter so as to guidethe barbs 3835 into the desired locations.

The device 3805 can exert a force between the atrium roof and the valveleaflet through the spring 3820 to hold the leaflet down and preventflail up into the left atrium LA. The tension can be adjusted by varyingthe spring coupled to the device prior to inserting it into the body.Alternatively, the desired length of the device after implantation canbe adjusted and tuned prior to introduction with an adjustable bolt andnut type design that limits how far one platform can move in relation tothe other. It should be appreciated that the embodiments of chordalreplacement devices described herein are exemplary and that variationsare possible.

In another embodiment shown in FIGS. 39A-390, a chordal replacementdevice 3905 can include a clip 3910, a distal anchor 3915 and a tether3920 extending therebetween. The clip 3910 can attach to a portion of aflailing leaflet LF and the distal anchor 3915 can extend into theventricle such that the flailing leaflet is held down. For example, theanchor 3915 can be implanted in the left ventricular wall or septum orpapillary head or other appropriate tissue site. The length of thetether 3920 can be variable and/or adjusted such that the tensionapplied to the leaflet LF by the chordal replacement device 3905 istailored to an individual patient's needs. For example, once the clip3910 is positioned, the tether 3920 can be tensioned, tied and trimmedas will be described in more detail below.

The clip 3910 can be an elastic element that can be deformed to attachit to a portion of the leaflet LF, such as by crimping. In anembodiment, the clip 3910 can be attached to a portion of the valveleaflet LF where flail occurs, for example it can be fastened to an edgeof the anterior or posterior mitral valve leaflet with the damagedchord. The clip 3910 can have surface feature 3950, such as small barbsor a textured surface, that aids in the capture of the leaflet LF upondeforming the clip 3910 to the leaflet LF. As best shown in FIG. 39A,the clip 3910 can also include an eyelet, aperture or other attachmentfeature 3945 that provides a location for coupling to or extending thetether 3920 through a portion of the clip 3910. The distal anchor 3915can similarly include an eyelet, aperture or attachment feature 3945that provides a location for the tether 3920 to couple to or extendthrough a portion of the anchor 3915 (see FIG. 39A, for example).

The anchor 3915 can vary in configuration and can include a weight,barb, corkscrew, adhesive or other mechanism such that the tether 3920extends down and is secured in place within the ventricle. In anembodiment, the anchor 3915 extends into the ventricle from the clip3910 and is secured to the bottom of the ventricle or toward theventricular septum or papillary head. In an embodiment, the barbs of theanchor 3915 can be collapsible such that they conform to a narrowconfiguration and fit within the lumen of the guide catheter and expandupon being advanced out of the guide catheter (see FIGS. 39B-39C).

As mentioned above, the tether 3920 can attach to the clip 3910 in avariety of ways. The clip 3910 can include an attachment feature 3945that provides a location for coupling the clip 3910 to the tether 3920.For example and as shown in FIG. 39D-39H, a knot or crimp 3930 can beapplied to one end of the tether 3920 such that end will lodge into aportion of the clip 3910 or will lodge into the attachment feature 3945.The opposite, unknotted end of the tether 3920 can extend through thedelivery catheter 3960 and be retracted until the crimp 3930 lodges withthe attachment feature 3945 on the clip 3910, which is attached to theleaflet LF. The delivery catheter 3960 can be used to deploy the clip3910 to the leaflet (FIG. 39E) and can then be withdrawn (FIG. 39F). Atthis stage the tether 3920 can still have both ends extending outsidethe body (FIG. 39G). An anchor 3915 also coupled to the tether 3920 canbe loaded over the tether 3920 and delivered to the ventricle as will bedescribed in more detail below.

In another embodiment shown in FIG. 39J-39M, the delivery system 3955for the chordal replacement device 3905 can include a guide catheter3966 having a lumen 3965 for a clip delivery catheter 3970 and a lumen3975 for an anchor pusher or mandrel 3980 used to push the anchor 3915out of the delivery system 3955. The anchor 3915 is shown as a barbedanchor, but it should be appreciated that other configurations areconsidered herein. The anchor 3915 can be attached to a distal end ofthe mandrel 3980 such as by corresponding threads 3990 or anothercoupling mechanism. Upon being pushed out the distal end of the guidecatheter 3966, the anchor 3915 can be uncoupled from the mandrel 3980(such as by an unthreading rotation) and released in its position withinthe heart. Alternatively, the anchor 3915 can be unattached to themandrel 3980 and simply pushed out the distal end of the guide catheter3966. Once the anchor 3915 is implanted, the mandrel 3980 can bewithdrawn.

It should be appreciated that the clip 3910 can be deployed prior to,during or after delivery of the anchor 3915. The embodiments of FIGS.39D-39H and FIG. 39K illustrate the deployment of the clip 3910 prior tothe anchor 3915 being delivered. FIGS. 39L-39M illustrate an embodimentin which the clip 3910 is deployed after the anchor 3915 is delivered.

As mentioned above, once the clip 3910 is positioned on the leaflet LFand the anchor 3915 deployed and secured within the ventricle, thetether 3920 can be tensioned. For example, the tether 3920 can be pulledmanually to tension an end of the tether 3920 extending outside thebody, to the desired tension to hold the leaflet LF down. Tension on thetether 3920 can be tuned and adjusted until an appropriate tension onthe leaflet LF is achieved evidenced by the tether 3920 simulating thetension of a healthy chord. The appropriate tension can be assessed asis known in the art. For example, an echocardiogram can be performed toassess leaflet flail or prolapse as well as the effect on mitralregurgitation. Once the appropriate tension is achieved, the tether 3920can be clamped and cut to remove the excess length of the tether 3920.FIGS. 39N-390 illustrate an embodiment of a dual-function cutting clamp3935 having the tether 3920 extending therethrough. The cutting clamp3935 can have dual functions and can be used to clamp onto the tether3920 to secure it near the distal end and it can also be used to cut thetether 3920 proximal of the secured section. As best shown in FIG. 39O,the cutting clamp 3935 can have an outer shell 3937 that can be coupledor attached to the anchor 3915. The shell 3937 of the cutting clamp 3935can have apertures or slots 3939 at opposite ends through which thetether 3920 can extend into an inner region of the shell 3937. From oneend of the shell 3937, the tether 3920 extends towards the clip 3910. Atthe opposite end of the shell 3937, the tether 3920 extends back throughthe delivery catheter 3970 to the outside of the body. The cutting clamp3935 can also include an aperture or slot 3941 through which an actuatorline 3943 can pass and extend to the outside of the body. The actuatorline 3943 can be actuated to effect clamping and/or cutting of thetether 3920 with the cutting clamp 3935.

Still will respect to FIG. 39O, the cutting clamp 3935, which may or maynot already be coupled to the anchor 3915 can be actuated such that thetether 3920 is engaged by a ratcheting clamp mechanism. The ratchetingclamp mechanism prevents the release of the tension on the tether 3920.The ratcheting clamp mechanism can include opposing clamp elements 3946that extend inward from a ratchet recess 3947 open at an inner surfaceof the shell 3937. The opposing clamp elements 3946 have texturedsurfaces at one end that are designed to come together to releasablyengage the tether 3920. At an opposite end the opposing clamp elements3946 can have a ratchet mechanism 3949 that engages correspondingfeatures in the ratchet recess 3947 of the shell 3937. The opposingclamp elements 3946 can be actuated by pulling the actuator line 3943 atthe outside of the body. The actuator line 3943 engages the opposingclamp elements 3946 such that they extend out from the ratchet recess3947 and approach one another until the tether 3920 is caught betweentheir textured surfaces. After the opposing clamp elements 3946 areengaged with one another and the tension on the tether 3920 ismaintained, the actuation line 3943 can be actuated further until theopposing cutting elements 3951 are engaged by the actuation line 3943,extend from their respective ratchet recess 3947 until their cuttingsurfaces come in contact to cut the tether 3920 therebetween. Once thetether 3920 is cut by the opposing cutting elements 3951 the actuationline 3943 can be released and the loose end of the tether 3920 can beremoved from outside the body. In an embodiment, multiple chordalreplacement devices 3905 can be used to attach to the chordae on theopposite or same side as the flailing leaflet. The second chordalreplacement device 3905 can incorporate a similar cutting clamp asdescribed above.

In another embodiment as shown in FIG. 40A-40B, a chordal replacementdevice 4005 can include a flexible material or patch 4010 that can beattached to the valve leaflet LF. A single strand of artificial chordae4015 can loop through and underneath the patch 4010. The strand ofartificial chordae 4015 can include one, two, three or more individualloops and can be made of suture or another flexible material. The loopsof artificial chordae 4015 can be drawn together at one end with a ring4020 or other enclosed shape going through the loops of artificialchordae 4015. The ring 4020 can be attached to the ventricle wall orpapillary muscle or ventricular septum with a distal attachment assemblyas described in more detail below.

The loops of artificial chordae 4015 can be a single strand of materialthat freely slides through the patch 4010 and the ring 4020 such thatthe loops 4015 can self-equalize to evenly distribute the load. A singleloop 4015 can thread through the patch 4010 and the ring 4020, forexample three times, such that one loop is short and there are two otherloops that are long. Pulling the ring 4020 away from the patch 4010 willengage the short loop and redistribute the long loops to the length ofthe shortest loop such that the three loops are equally long and equallydistribute the force. The loops of artificial chordae 4015 are not fixedsuch that they can slip and distribute the force equally between them.This self-equalizing characteristic along with the flexible patch 4010reduces the stress on the leaflet LF.

As shown in FIGS. 41A-41B, the device 4005 can be delivered to the valveleaflet (posterior or anterior). The patch 4010 can be folded and loadedinto a delivery catheter 4025 such that the artificial chordae 4015trail behind and are delivered through a guide catheter 4030 to thevicinity of the valve. A mandrel or pusher tube 4035 can push the patch4010 out the distal end of the delivery catheter 4025 (see FIG. 41C).

The leaflet LF can be stabilized using a vacuum or a hook attached to aguidewire or another stabilizing device. In an embodiment shown in FIGS.41G-41N, the leaflet LF can be captured and/or stabilized using aguidewire 4141 having a distal end that has a needle point. The needlepoint guidewire 4141 can be delivered using a protective sheath ordelivery catheter 4143 that prevents pricking of the vessel as it ispassed therethrough. The sheath or delivery catheter 4143 can beretracted slightly exposing the distal needle point to the leaflet LF.The distal needle point can be urged through the leaflet LF near an edgeor positioned closer to the valve annulus. The needle point guidewire4141 can be pre-formed to have a hook shape such that when it isadvanced out of the sheath 4143 and extends through the leaflet LF itcan curve upward back toward the sheath 4143 to form a hook. In anotherembodiment shown in FIGS. 41O-41P, the guidewire 4141 can include athicker needle point 4145 attached to a more flexible cable 4147 orguidewire or thinner wire. The needle point 4145 can also be preformedsuch that it takes on a sharper curve or hook shape when advanced beyondthe distal end of the delivery catheter 4143. The needle point 4145 canbe formed of a variety of materials such as Nitinol or other shapememory alloy or other suitable material.

Tension can be applied to the needle point guidewire 4141 such that theleaflet LF remains hooked and stabilized. Alternatively, the chordae canprovide the resistance allowing the needle point guidewire 4141 topuncture the leaflet LF. The needle point guidewire 4141 as it forms thehook shape can penetrate the leaflet LF a second time (see FIG. 41K)although it should be appreciated that the guidewire need only penetratethe leaflet LF a single time to effect capture and stabilization (seeFIG. 41M). To release the leaflet LF from the needle point guidewire4141, the sheath 4143 can be advanced distally back over the needlepoint as shown in FIG. 41N. The portion of the guidewire 4141penetrating the leaflet LF is slowly withdrawn as the sheath 4143 isadvanced distally.

The patch 4010 can be affixed to the valve leaflet LF by activating aleaflet attachment device 4040 through the guide catheter 4030. In anembodiment, the leaflet attachment device 4040 can include a pair ofexpandable elements 4045 connected centrally by a rod 4050. One or moreof the expandable elements 4045 can have a sharp needle point 4055. Thepatch 4010 can lie on top of the valve leaflet LF and the sharp needlepoint 4055 of the leading expandable element 4045 can pierce through thepatch 4010 and the leaflet LF such that the leading expandable element4045 emerges from the underneath side of the leaflet LF and the rod 4050extends through the leaflet (see FIGS. 41D and 41E). The patch 4010 onthe upper surface of the leaflet LF can be sandwiched between theleading and trailing expandable elements 4045 of the leaflet attachmentdevice 4040. The leaflet attachment device 4040 and each of theexpandable elements 4045 can be a shape-memory metal (e.g. Nitinol,Nitinol alloys) or some other spring material. The spring material ofthe expandable elements 4045 allows them to spring out as the leafletattachment device 4040 is advanced from the distal end of the deliverycatheter 4025. The leaflet attachment can be facilitated by stabilizingthe leaflet as described above. The position of the patch prior tosecurement of the expandable element 4045 can be maintained for example,by attaching the patch to the first expandable element prior to beingdeployed from the delivery catheter. The delivery catheter can then beused to maneuver into position the patch prior to deploying the firstexpandable element.

FIG. 41F shows a top view of an expandable element 4045 deployed on theupper surface of the leaflet. The embodiment is shown having barbed armsin a star-shaped configuration although it should be appreciated thatother shapes and configurations are considered. For example, as shown inFIGS. 42A-42B, the leaflet attachment device 4040 can include expandableelements 4045 of a spring metal mesh. The spring metal mesh expandableelement 4045 can form a web shape and flatten out as it is deployed.Alternatively, the Nitinol or other spring material can spring into anexpandable element 4045 shaped like a mesh ball (see FIG. 42C). Uponexpansion, the mesh ball expandable element 4045 can protectively coverthe sharp needle point 4055 on the underneath side of the valve leaflet.It should also be appreciated that the leaflet attachment device 4040can include expandable elements 4045 that are a combination ofconfigurations including flat mesh design, ball mesh design, astar-shaped design or other configuration. For example, one expandableelement 4045 can have a star-shaped design and the other expandableelement 4045 can have a mesh ball design (see FIG. 42D). The expandabledevices such as the mesh ball design can be collapsed sufficiently smallto pass through a needle hole without ripping the leaflet. In anembodiment, the needle bore can be a larger hypotube such that insertionof the tube needle can punch a hole in the leaflet. The patch 4010 cancover the hole such that leaks are avoided. Further, the hypotube can bedull at the base of the bore such that punched out tissue remainsattached to avoid creation of an embolism.

It should be appreciated that more than one leaflet attachment device4040 can be used to affix a patch 4010 to the valve leaflet LF. As shownin FIG. 43A, the patch 4010 can be attached to the atrial side of thevalve leaflet LF with multiple leaflet attachment devices 4040 orientedside-by-side on the upper and lower surface of the leaflet LF. Usingmultiple leaflet attachment devices 4040 to affix the patch 4010 reducesstress in the leaflet LF, in part, due to distribution of forces acrossmultiple attachment locations. As shown in FIG. 43B, the multipleleaflet attachment devices 4040 can be stacked and deployed in seriesfrom a delivery catheter 4025. In another embodiment, the multipleleaflet attachment devices 4040 can be deployed using a guide wirebetween deployments of each leaflet attachment device 4040. For example,the patch 4010 can be deployed followed by the first leaflet attachmentdevice 4040. The delivery catheter 4025 can be withdrawn leaving a guidewire 4060 in place. Another catheter with the second leaflet attachmentdevice 4040 can then be advanced along the guide wire 4060 and thesecond leaflet attachment device 4040 deployed. The process can berepeated depending on the number of attachment devices desired to bedeployed.

Once the patch 4010 is positioned and affixed to the leaflet LF, such aswith the leaflet attachment device(s) 4040, the loops of artificialchordae 4015 can be deployed distally within the ventricle such as tothe ventricular wall, septum or papillary muscle. As shown in FIG. 44A,the delivery catheter 4025 that deployed the patch 4010 and leafletattachment device(s) 4040 can be removed from the guide catheter 4030leaving a guide wire 4060 attached to a ring 4020 through which theartificial chordae 4015 loop (attachment device(s) are not shown in thefigure for simplicity). The guide wire 4060 can be previously loopedthrough the ring 4020, for example, during manufacturing. Anothercatheter can be advanced over the guide wire 4060 through the guidecatheter 4030. In an embodiment, the ring 4020 is attached to the distalend of the catheter 4030 as shown in FIG. 44B-44C. For example, the ring4020 can be inserted or snapped into a flanged channel 4065 near thedistal end of the catheter 4030 using the guide wire 4060 looped throughthe ring 4020. The catheter 4030 with the ring 4020 in the channel 4065can advance through the valve distally into the ventricle (see FIG.44D).

As shown in FIGS. 45A-45D, the ring 4020 with the attached loops ofartificial chordae 4015 can be anchored to the ventricular wall orpapillary muscle forming a distal attachment assembly 4070 of thechordal replacement device. In an embodiment a coil screw 4075 iscoupled to the distal attachment assembly 4070. The coil screw 4075 canbe advanced like a cork screw through the distal end of the catheter4030 into the ventricular tissue, for example, by rotating an actuatorknob on the proximal end of the catheter. The rotation of the actuatorknob can rotate the coil screw, advancing it out of the catheter andinto the ventricular tissue.

In another embodiment, the distal attachment assembly 4070 can becoupled to or can include a fillable element 4080 delivered through ahollow needle 4085 that pierces the ventricular wall (See FIGS.45B-45C). The fillable element 4080 can include a balloon or mesh bag orother expandable element. A hardening agent or other material can beused to fill the element 4080 expanding it such that it anchors theartificial chordae 4015 and the distal attachment assembly 4070 to theventricle. The needle 4085 can be retracted leaving the filled element4080 inserted in the ventricle wall and coupled to the distal attachmentassembly 4070. The hardening agent can be a two-part hardening agent,such that a small quantity of a second agent can be delivered throughanother smaller tube in the catheter to activate the first part and mainbulk of the hardening agent.

After the distal anchor (e.g. coil screw 4075 or filled element 4080) ofthe distal attachment assembly 4070 is attached to the ventricular wallor papillary muscle, the distal attachment assembly 4070 can be releasedfrom the guide catheter 4030. The assembly 4070 can be released, forexample, using a mandrel that runs through the catheter and has athreaded end that threads into the distal attachment assembly. Inanother embodiment, the distal end of the catheter can be a sleeve thatpinches circumferentially onto the attachment assembly and then byretracting a lever proximally, a mandrel is retracted which pulls thepinching sleeve backwards over the catheter slightly, expanding thepinching sleeve and releasing the attachment assembly. The two ends ofthe guide wire 4060 can extend all the way up through the guide catheter4030. As the delivery catheter 4025 is removed, the guide wire 4060 canstill be looped through the ring 4020. The guide wire 4060 can beremoved before, during or after the delivery catheter 4025 is removed.The guide wire 4060 can be removed by pulling one end, allowing thetrailing end to pull through the ring 4020 and then out of the guidecatheter 4030 leaving the distal attachment assembly 4070 anchored inthe ventricle and the artificial chordae 4015 extending up to the valveleaflet LF where the patch 4010 is affixed to the leaflet LF with theleaflet attachment device(s) 4040.

Once the chordal replacement device is deployed, the tension of theartificial chordae 4015 can be adjusted. In an embodiment, a sensor 4090such as a pin or pressure sensor can be used to adjust tension in theartificial chordae 4015. The sensor 4090 can provide the user withinformation regarding contact between the guide catheter 4030 and theventricular wall. As shown in FIG. 46A-46B, the sensor 4090 can includea pin 4095 near the distal tip of the catheter 4030. The pin 4095 isshown in FIG. 46A as fully extended indicating no contact with theventricular wall. Upon contact with the wall as shown in FIG. 46B, thepin 4095 can compress and activate delivery of a signal to the user suchas an electrical signal or visual signal indicating that contact is madewith the wall of the ventricle. If the sensor 4090 indicates contactwith the ventricular wall and an echocardiogram suggests no flail orprolapse and mitral regurgitation (MR) is reduced then the distal anchor(e.g. coil screw 4075 or element 4080) can be advanced into theventricular wall to secure attachment. If the sensor 4090 indicatescontact with the ventricular wall, but the echocardiogram suggests flailand/or prolapse and poor MR results, the catheter 4030 can be movedfurther down into the ventricle to increase tension on the artificialchordae 4015 and the test repeated. If the sensor 4090 indicates contactwith the ventricular wall, and the echocardiogram suggests no flailand/or prolapse but the MR results are still poor, the leaflet is pulleddown too far and the catheter 4030 can be moved proximally to releasetension on the artificial chordae 4015. The test can be repeated untildesirable results are achieved.

Once the distal anchor is advanced into the ventricular wall andadequate results are obtained, fine-tuning of the tension can beperformed (see FIG. 47). In an embodiment, the distal anchor can be acoil screw 4075 that is advanced and locked. The distal attachmentassembly 4070 can be rotated clockwise by the catheter 4030 to draw thering 4020 slightly closer to the ventricular wall. The distal attachmentassembly 4070 can also be rotated by the catheter 4030 in acounter-clockwise direction to push the ring 4020 away such that thevalve leaflet LF can rise up slightly.

In another embodiment as shown in FIGS. 48A-48B, the distal anchor canbe an expandable element, such as a balloon anchor filled with atwo-part epoxy as described above. This embodiment can also befine-tuned. As the expandable element 4080 expands within theventricular wall, the distal attachment assembly 4070 attached to theexpandable element 4080 is pulled toward the ventricular wall. Thematerial of the expandable element 4080 can be finitely expanded suchthat fine-tuning of the distance between the distal attachment assembly4070 and the ventricular wall can be performed. As the expandableelement 4080 is unexpanded the artificial chordae 4015 can pull thedistal attachment assembly 4070 away from ventricular wall and the valveleaflet can rise slightly. Once gross adjustments are performed,fine-tuning the tension on the artificial chordae 4015 attached to thevalve leaflet can be performed. The first part epoxy (i.e. prior tohardening) can be used to fill the expandable element 4080 and alsofine-tune the positioning and tension on the chordae 4015. Once theproper position is confirmed, the second part of the epoxy can beinfused such that it hardens and sets in place the chordae. It should beappreciated that the epoxy can be embedded directly into the attachmentsite or can be used to fill a expandable element pre-embedded in thedistal attachment site. Ideally, very little of the second part epoxy isused so as not to interfere with the fine-tuning achieved.

The chordal replacement device need not include a distal attachmentassembly 4070 (see FIGS. 49A-49B). For example, the chordal replacementdevice can be attached to an attachment assembly that is deployedproximal to the valve. In an embodiment, the chordal replacement devicecan include a ring 4020 and loops of artificial chordae 4015 attached toa rod 4105 extending from a spring material (e.g. shape-memory metalsuch as Nitinol or other material) that forms a stent-like mesh 4100deployed in the left atrium, just above the mitral valve. The rod 4105can be attached to the mesh 4100 and extend from the mesh 4100 throughthe mitral valve such as at one of the commissures into the ventricle.The rod 4105 can be straight or curved or jointed. The distal end of therod 4105 can be attached to the ring 4020 such as by extending throughthe ring 4020. Rod 4105 and mesh 4100 can be moved to adjust tension onthe artificial chordae 4015. Once in a desirable location and thedesired tension is achieved, the mesh 4100 and rod 4105 can be securedwithin the atrium or to the valve leaflets, for example using theleaflet attachment devices 4040 discussed above (see FIG. 49B; note therod, ring and replacement chordae are not shown).

As shown in FIG. 50A, the rod 4105 and mesh 4100 can be deliveredthrough a delivery catheter 4025 in which the mesh 4100 is collapsed. Asmentioned above, the rod 4105 can be jointed. The joints 4110 can lockin place once the rod 4105 is deployed and/or can have limited travelaround the joint 4110. As shown in FIGS. 50C-50E, one or more of the rodjoints 4110 can lock into place using a mechanical/physical featureincorporated within the joint 4110. In an embodiment, one or more of thejoints 4110 can have a surface feature 4112 such that when the rod 4105rotates over the surface feature 4112 on the adjacent portion of thejoint 4110 it can pop over and lock in place relative to the adjacentportion of the joint 4110.

Even in the locked position, one or more of the joints 4110 can havelimited travel around the joint 4110 to provide the artificial chordae4015 with some degree of slack (see FIG. 50B). The rod 4105 and mesh4100 can passively rise and fall with the mitral annulus during thecardiac cycle. In diastole, when the annulus rises, excessive tension onthe artificial chordae 4015 can be avoided due to this limited travelaround the joint 4110. In an embodiment, the top joint 4110 can lock andthe bottom joint does not lock. In this embodiment, the lower joint canpivot without detriment to the system as the annulus rises duringdiastole. During systole, the lower joint can pivot in the oppositedirection due to tension on the chordae until the physical stopincorporated in the joint limits the travel. In this position the rodsystem can then provide tension to the chordae and hold the leafletsdown. As shown in FIG. 50F, the top joint 4110 rather than being fixedcan pivot about an axis that is orthogonal to the axis of the bottomjoint. This arrangement can prevent the forces of the cardiac cycle frombending the top joint once deployed.

With reference to FIGS. 51A-51B, rather than using a jointed rod, therod 4105 can be flexible so that it can fit in a delivery catheter 4025and expand to its spring-formed shape when deployed from the deliverycatheter 4025. Flexibility of rod 4105 can be designed so that itprovides a predictable spring force on the artificial chordae 4015. Therod 4105 can deflect and provide consistent tension on the artificialchordae 4015.

It should be appreciated that in addition to a chordal replacementsystem, the leaflet attachment devices 4040 described above can be usedto attach a leaflet extension patch for the treatment of mitral valveprolapse or flail. As shown in FIGS. 52A-52C, the leaflet extensionpatch 5210 can be attached to the atrial side of the valve leaflet. Theleaflet extension patch 5210 can be a stiff or a flexible material. Theleaflet extension patch 5210 can prevent mitral regurgitation in thecase of prolapse or flail in that it can block the leaflet from flailingupwards into the atrium. For functional mitral regurgitation, theleaflet extension patch 5210 can bridge any coaptation gap between theleaflets.

FIG. 52A shows the leaflet extension patch 5210 during diastole. Thepatch 5210 can follow the leaflet downwards such that flow through thevalve is not impeded. During systole, the leaflet extension patch 5210can block flow by coapting with the opposite leaflet LF as well asprevent flail or prolapse by physically blocking it from moving upwardsinto the atrium (see FIGS. 52B and 52C).

Other embodiments are directed to atrial or ventricular remodeling toalter the shape of an atrium or ventricle. Now with respect to FIG. 14which shows a cross-sectional view of the heart with a first and secondanchor attached to a wall of the heart. The system includes a firstanchor 1410 a having a screw portion 1415 for screwing into a wall ofthe heart and a connector portion. The connector portion is rotatablearound an axis of rotation. The first anchor includes a power source topower rotation of the connector portion and a receiver for receivingtelemetric signals from an external controller for controlling therotation of the connector portion. The system includes a second anchor1410 b having a screw portion 1415 b for screwing into a wall of theheart and a connector portion. Also included is a tether 1420 having twofree ends. One of the free ends is coupled to the connector portion ofthe first anchor, and the other free end is coupled to the connectorportion of the second anchor. An external controller is also included.The external controller has a telemetric transmitter for communicatingwith the receiver and controls the rotation of the connector portion.Alternatively, the anchors may be placed with a torqueable catheter.

In another embodiment, a method of altering a geometry of a heartincludes introducing a first coupler into a heart chamber. The firstcoupler has an anchor portion and a connector portion. The connectorportion is rotatable around an axis of rotation and is connected to apower source to power rotation of the connector portion. The powersource is in communication with a telemetric signal receiver. The firstcoupler is secured to the wall of the heart chamber by anchoring theanchor portion to the wall. A second coupler is introduced into theheart chamber. The second coupler includes an anchor portion and aconnector portion. The second coupler is secured to the wall of theheart chamber by anchoring the anchor portion to the wall at a distancefrom the first coupler.

A tensile member is introduced into the heart chamber. One end of thetensile member is connected to the connector portion of the firstcoupler, and another end of the tensile member is connected to theconnector portion of the second coupler. The distance between the firstand second couplers is adjusted by transmitting a telemetric signal tothe receiver, thus causing the connector portion to rotate around theaxis of rotation and threading the tensile member around the connectorportion to reduce the distance between the first and second couplers.

In another embodiment, a system for altering the geometry of a heartchamber includes a planar tensile member having substantially inelasticmaterial. At least two anchors are included for anchoring the planartensile member to an inner wall of a heart chamber. The planar tensilemember is substantially shorter in length than a left ventricle of aheart so that when the planar tensile member is anchored in a caudaldirection along a length of the left ventricle a tensile force exertedby the planar tensile member between the two anchors prevents the leftventricle from dilating caudally.

In another embodiment, a method for altering the geometry of a heartincludes providing a tensile member having a substantially inelasticmaterial. The tensile member is substantially shorter in length than aleft ventricle of a heart. The tensile member is inserted into the leftventricle of the heart and a proximal end of the tensile member isanchored to the left ventricle adjacent the mitral valve. A distal endof the tensile member is anchored to the left ventricle caudal theproximal end so that a tensile force exerted by the tensile memberbetween the two anchors prevents the left ventricle from dilatingcaudally.

Other embodiments are directed to strengthening or reshaping the leftventricle of the heart. In one embodiment in particular, a method ofreinforcing the left ventricle includes injecting a strengthening agentinto a wall of the left ventricle in an enlarged region of theventricle, as shown in FIG. 15. FIG. 15 shows a catheter 1510 that hasbeen introduced into the heart. The catheter 1510 has an internal lumenthrough which the strengthening agent 1512 can be injected. A proximalend of the catheter is connected to a source of the strengthening agentand a distal end of the catheter is configured to release thestrengthening agent. As shown in FIG. 15, the distal end of the catheteris positioned at or near a wall of the heart and the strengthening agent1512 is injected into the wall of the heart.

In another embodiment, a method is directed to altering the geometry ofa heart. The method includes injecting a polymerizing agent into apericardial space adjacent a left ventricle, thereby exerting a medial(inward) force against the left ventricle.

In yet another embodiment, a method of altering the geometry of a heartincludes inserting a balloon into a pericardial space adjacent to a leftventricle of the heart, or extend into the pericardium of the heart. Theballoon is inflated by injecting it with a fluid, and it exerts a medialforce against the left ventricle upon inflation. In certain embodiments,the balloon can be inflated at the time of implantation, or at a latertime. If inflated at a later time, the balloon would be self-sealing,and may be inflated by accessing the balloon with a needle placedthrough the chest wall.

Other embodiments are directed to adjusting the length or orientation ofpapillary muscles. FIG. 16 shows a schematic view of the heart showingthe papillary muscles PM. With reference to FIG. 16, a method oftreating heart disease includes inserting an anchor, cuff or sleeve 1205into the left ventricle of an individual's heart, and sliding a cuff orsleeve around a papillary muscle PM. The size of the cuff or sleeve isreduced so that the cuff or sleeve squeezes the papillary muscle. As thesize of the cuff or sleeve is reduced, the papillary muscle stretchesand increased in length.

In yet another embodiment, a method of treating heart disease includesobtaining access to a papillary muscle in a left ventricle of the heart.The papillary muscle is cut and reattached at a new location on an innerwall of the ventricle closer to the mitral valve.

Additional embodiments that employ magnets in the heart are nowdescribed with reference to FIGS. 17-19, which show cross-sectionalviews of the heart. With reference to FIG. 17, in one embodiment one ormore magnets 1705 are implanted or otherwise attached to a wall 1710 ofthe left ventricle LV. One or more other magnets 1715 are implanted orotherwise attached to a wall 1720 of the right ventricle. The magnets1705 and 1715 are attached to the walls 1710 and 1720 such that theyassert an attractive magnetic force (as represented by the arrows 1725in FIG. 17) toward each other. The magnetic force 1725 assists inremodeling of the left ventricle during pumping of the heart. That is,the magnets 1705 and 1715 are urged toward one another (thereby alsourging the walls 1710 and 1720 toward one another) to re-shape eitherthe annulus AN or the left ventricle LV. The annulus or the leftventricle LV are re-shaped in a manner that reduces or eliminatesbackflow through the mitral valve MV. It should be appreciated that asimilar procedure can be performed on the right ventricle RV andassociated valves.

FIG. 18A shows another embodiment of a procedure wherein magnets areimplanted in the heart to geometrically reshape the annulus or the leftventricle. One or more magnets 1705 are implanted or otherwise attachedto a first wall 1710 a of the left ventricle LV. One or more magnets1705 are also implanted or otherwise attached to a second, opposed wall1710 b of the left ventricle. The magnets on the opposed walls 1710 a,1710 b exert an attractive magnetic force toward one another to draw thewalls 1710 a, 1710 b toward one another and re-shape the left ventricleLV or the annulus AN.

Another embodiment of a procedure uses magnets to anchor tethers withinthe heart at various locations to optimize the shape of cardiacstructures to improve cardiac function. The tethers are placed to eitherreshape the cardiac structure or to prevent dilatation of the structureover time. The tethers must be securely anchored to the heartstructures. A method of anchoring which enables tethering in variouspositions and directions within the cardiac structures is important forthe clinician to optimize cardiac reshaping based on each individualpatient anatomy and disease state. A method of anchoring which isatraumatic is also desirable.

FIG. 18B shows a side view of the heart with sets of magnets A, A1, B,and B1 positioned to various locations of the heart or to anatomicalstructures adjacent the heart. In one embodiment, at least one magnet Ais placed on the interventricular septum within the right ventricle RV.At least one magnet A1 is placed within the left ventricle LV oppositemagnet A. The magnetic force between A and A1 maintains the position ofthe magnets. The magnets may be enclosed in materials that will promotetissue in-growth and healing to the interventricular septum to ensurestability of location and to eliminate the need for long termanti-coagulation. Additionally, the enclosure material which is flexibleand can be delivered in a low profile can be significantly larger insize than the magnets to increase the surface area of contact with theheart wall which will increase the tension that can ultimately be placedon the anchor over time.

A second set of magnets B and B1 are then delivered to another locationselected within or adjacent to the heart. The set of magnets A/A1 areattached to the set of magnets B/B1 using at least one tether 1805, asshown in FIG. 18B. The tether 1805 can be attached to either or both ofthe magnets A/A1 at one end and to either of both of the magnets B/B1 atan opposite end. When the set of magnets B/B1 are tethered under tensionto the set of magnets A/A1, a change in the shape of the cardiacstructure results to improve cardiac function. FIG. 18B shows magnet Bpositioned in the LV and B1 positioned in a blood vessel BV adjacent tothe heart. The magnetic force between B and B1 maintains the location ofB and B1. Magnets B and B1 are delivered on or within materials andstructures which promote healing and increase the amount of tension thatcan be placed on the anchor over time. For example, magnet B1 can bedelivered on a stent which is of a length, diameter and material whichwill heal within the BV to provide sufficient resistance to forcesplaced on it by the tethers.

The tethers may be pre-attached to the magnets A and B1 or they may beattached after A and B1 have been positioned. The tether length may beshortened and/or adjusted after placement of the anchors. Alternativelythe final tether length may be pre-selected based on the patient'scardiac structure geometry and the effect the clinician desires. Placingsets of magnets in this method, enables anchoring of tethers within theheart in various positions and angles which provides increasedflexibility and variation for clinicians to select optimal re-shaping ofthe cardiac structures based on specific patient characteristics.

Examples which demonstrate the flexibility of this approach includeplacing anchors at the annulus and at the apex of the heart and tetheredto shorten the length of the LV; anchors can be placed in the around theannulus and tethered to change the shape of the annulus. Morespecifically, one or more sets of magnets can be placed in the RA and LAat the level of the mitral valve annulus (on the anterior side of theannulus) and one or more sets of magnets can be placed in the LA and LVon opposite sides of the annulus on the posterior portion of theannulus. The posterior sets of magnets can then be tethered to theanterior sets of magnets to change the shape of the annulus.Alternatively, the magnet anchors can be placed at the level of theannulus in the LA and in a BV adjacent to the heart at the level of theannulus and these then tethered to the anterior annulus magnet anchordescribed above.

The magnets A and A1 can also be a single magnet that extends throughthe interventricular septum. Moreover, only one of the magnets A or A1need be implanted. One or more magnets B and/or B2 are located oppositethe location of the magnet(s) A and/or A1. The magnet(s) B is locatedwithin the left ventricle opposite the magnets A/A1, such as on the leftventricular wall. The magnet B1 is located on an anatomical structureadjacent the heart, such as on a blood vessel BV.

In another embodiment shown in FIG. 18C, the magnets A, A1, B, and B1,or combinations thereof, are implanted in the heart without tethers. Themagnets A, A1, B, and B1 can be positioned in various combinations so asto exert magnetic attractions to one another to re-shape the leftventricle or the mitral valve annulus. For example, the magnets A and Bcan be implanted such that they exert an attractive magnetic forcerelative to one another. The magnets A and B2 can alternately beimplanted. Other possible combinations are the magnets A1 and B or themagnets A1 and B2. The magnets can be implanted without tethers suchthat an attractive magnetic force F causes the magnets and the attachedregion of the heart to move toward one another to re-shape the heart.Alternately, the magnets can be attached to one another with tethers.

In yet another embodiment, one or more magnets 1705 are implanted in thewalls 1710 of the left ventricle LV and/or the right ventricle RV, asshown in FIG. 19. The magnets 1705 are positioned in opposed locationson the walls 1710 and one or more tethers 1905 attach opposed pairs ofmagnets 1705 to one another. One or more of the tethers 1905 extendthrough the interventricular septum to connect a first magnet disposedin the left ventricle and a second magnet disposed in the rightventricle. In certain embodiments, magnet elements do not includetethers, but rely on the magnetic attraction to each other to remodelthe tissue between them. For example, a magnetic element may be placedon either side of the interventricular septum, or one element within theseptum. Another magnetic element may be placed on or within the oppositeleft ventricular wall, or in an adjacent vessel on the left ventricularwall. The electromagnetic field of such elements can then interact tocause a remodeling of the left ventricle to assist with ventricularfunction.

The tethers 1905 can be elastic so to exert an attractive force betweenthe attached magnets 1705 and re-shape the left ventricle LV or annulusAN. Alternately, or in combination with elastic tethers, the tethers1905 can be shortened in length after placement to thereby pull thewalls of the left ventricle LV toward one another and re-shape the leftventricle LV or the annulus AN. In combination with the force providedby the tethers 1905, the magnets 1705 exert an attractive magnetic forcetoward one another to assist in pulling the heart walls toward eachother.

It should be appreciated that one or more magnets can be positioned inother locations of the heart or adjacent anatomical structures forre-shaping of the heart. For example, one or more magnets can bepositioned around the annulus AN or can be positioned in the coronarysinus in such a manner that the magnets exert attractive forces towardone another to cause re-shaping of a desired portion of the heart.

In another embodiment, cardiac re-shaping is achieved throughpercutaneous placement of one or more tethers that are cinched oranchored in the walls of the left ventricle LV. The tethers providetension between the walls of the left ventricle to reshape the leftventricle LV in a desired manner. FIG. 20 shows a cross-sectional viewof the left ventricle LV with a tether 2010 positioned therein. Thetether 2010 has a first end anchored to a first wall of the leftventricle LV and a second end anchored to an opposed wall of the leftventricle LV. The tether 2010 is tensioned to pull the walls toward oneanother (as represented by the phantom lines 2012 in FIG. 20) andre-shape the left ventricle LV. It should be appreciated that thephantom lines 2012 in FIG. 20 are merely representative of the geometricre-shaping. The left ventricle LV can be re-shaped in various mannersand the amount of re-shaping can vary depending on the tension appliedto the tether 2010 and the location of attachment to the walls of theleft ventricle LV. The tether may be inelastic or somewhat elastic.

The tether 2010 can be anchored or otherwise attached to the walls invarious manners. In an exemplary embodiment, a patch 2015 (shown in FIG.20) of material is positioned on an exterior surface of the ventricularwall and is attached to one end of the tether 2010. A similar patch canalso be positioned on the opposed wall and attached to the opposite endof the tether.

With reference to FIG. 21, the patch is delivered to a desired locationusing a catheter 2105 having a sharpened distal end 2110 that ispositioned within the left ventricle LV. The catheter 2105 can bedelivered to the left ventricle LV in various manners, includingtrans-aortically (via the aorta), trans-septally (by piercing theinterventricular septum), and trans-atrially (via the left atrium LA)pursuant to well-known methods. As shown in FIG. 22, the sharpeneddistal end 2110 pierces the ventricular wall such that the distal end2110 is positioned exterior to the ventricular wall. The catheter 2105has an internal delivery lumen having an opening at the distal end 2110.The patch 2015 is configured to be transported in a contracted statethrough the delivery lumen and delivered out of the opening at thedistal end 2110, where the patch 2015 expands into an expanded state atthe exterior of the ventricular wall to seal against the exterior of theleft ventricular wall.

When positioned at the exterior of the ventricular wall, the patch 2015is configured to act as a reservoir that receives a fluid material thatcan be delivered to the patch via the delivery lumen of the catheter2105. The fluid material has a first viscous state of sufficientfluidity such that the material can flow through the delivery lumen ofthe catheter 2105 and out of the distal end 2110 to the location of thepatch 2015. The fluid material changes to a second viscous state whenpositioned exterior to the ventricular wall at the patch 2015. Thesecond viscous state is of greater viscosity (i.e., more resistant toflow) than the first viscous state such that the fluid material providessupport and a level of rigidity to the patch 2015 and to the leftventricular wall. The fluid material can change to the second viscousstate after a predetermined time period, after contact with the patch,or when the patch is completely filled. A catalyst can be injected intothe fluid material to cause it to change to the second viscous state.

As shown in FIG. 23, the catheter 2105 can then be disengaged from thepatch 2015 such that the patch 2015 is disposed exterior to theventricular wall. The patch 2015 can be firmly attached to theventricular wall (such as using an adhesive) to minimize wear orfriction between the patch and the ventricular wall. Next, an end of thetether 2010 is attached to the patch 2015. The catheter 2105 can be usedto deliver the tether 2010 to the patch 2015 or, alternately, a secondcatheter can be used. In one embodiment, the tether 2010 is alreadypositioned in a delivery lumen of the catheter 2105 while the patch 2015is being delivered. The catheter 2105 is then pulled back while the endof the tether 2010 remains attached to the patch 2015 to thereby let thetether 2010 out from the catheter 2105, as shown in FIG. 23.

With reference now to FIG. 24, a second patch 2415 is deployed in orexterior to an opposed ventricular wall in a manner similar to thatdescribed above. The opposite end of the tether 2010 is then attached tothe second patch 2415 such that the tether 2010 extends between the twopatches, as shown in FIG. 20. Alternately, as shown in FIG. 24, a secondtether 2420 is attached at a first end to the second patch 2415. Asshown in FIG. 25, the two tethers 2010 and 2420 can then be attachedtogether at opposite ends from the patches, such as by using a clip2510, to form a single attachment tether between the patches 2015 and2415. The tethers 2010 and 2420 can be twisted or adjusted within theclip 2510 to tension the resulting attachment tether between the patches2415 and 2015 and pull the ventricular walls toward one another via thetether. Once properly tensioned, the tether can be clipped or clamped tomaintain its position.

In another embodiment, shown in FIG. 26, a needle 2610 or deliverycatheter is passed trans-thoracically into the left ventricle LV todeliver a patch 2615 to the exterior of the ventricular wall, asdescribed above. A sealing means, such as a sealing balloon, can be usedto seal one or more puncture holes in the wall of the left ventriclecaused by the needle 2610 during delivery of the patch 2615.Visualization means, such as fluoroscopy, can be used to visualizeproper placement of the needle 2610. A second patch is attached to anopposed wall to form a tether attachment between the walls, as shown inFIG. 20. The tether is then tensioned to pull the walls together andre-shape the left ventricle or annulus of the mitral valve in a desiredmanner.

In other embodiments, described with reference to FIGS. 27-31, cardiacre-shaping is achieved by manipulation of the papillary muscles. FIG. 27shows a schematic, cross-sectional view of the left ventricle LV in ahealthy state with the mitral valve closed. The valve chordae CH connectthe leaflets LF of the mitral valve to the papillary muscles PM. Thepapillary muscles PM and the and chordae CH are positioned such that atleast a portion of the leaflets LF contact one another when the mitralvalve is in the closed state, resulting in functional coaptation of theleaflets.

FIG. 28 shows the left ventricle LV in a dysfunctional state. The valvechordae CH or the papillary muscles PM are damaged or otherwisedysfunctional such that the leaflets LF do not properly coapt (contactone another). The dysfunction can be manifested by excess tension in thechordae CH such that a gap is located between the leaflets LF, or insome cases one leaflet may function at a different level from the other(e.g. lower (prolapse) or higher (flail)) thereby limiting the abilityof the mitral valve to close resulting in mitral regurgitation. Thedysfunctional left ventricle LV and in some cases leaflet prolapse orflail, can be treated by manipulating papillary muscles PM to adjust theposition of the leaflets LF. In one embodiment, the papillary muscles PMare repositioned toward one another to reduce the distance between thepapillary muscles PM.

In an embodiment described with reference to FIG. 29, a biasing member,such as a rod of adjustable length, or a spring 2910, is mounted betweenthe papillary muscles PM with a first end of the spring 2910 attached toa first papillary muscle and a second end of the spring 2910 attached toa second papillary muscle. The spring 2910 has a pre-load such that thespring 2910 provides a biasing force (represented by the arrows 2915 inFIG. 29) that pulls the papillary muscles PM toward one another. Such aspring may be covered with polyester fabric or other coating to promoteingrowth into the muscle tissue and minimize the potential for clotformation. The repositioning of the papillary muscles PM re-shapes theleft ventricle and/or changes the distance that the leaflets need tomove on the chordae CH such that the leaflets LF contact one another toclose the mitral valve. The tension provided by the spring 2910 can bevaried or different springs can be used to achieve a properrepositioning of the papillary muscles PM. The tension may be modifiedat the time of the procedure or during a subsequent procedure if it isdetermined that additional coaptation is required.

In another embodiment, described with reference to FIG. 30, a suture3010 is mounted between the papillary muscles PM with a first end of thesuture 3010 attached to a first papillary muscle and a second end of thesuture 3010 attached to a second papillary muscle. The suture 3010 canbe attached to the papillary muscles in various manners. For example, anattachment device 3015, such as an anchor, cuff or sleeve, can bepositioned around or partially around each of the papillary muscles. Theends of the suture 3010 are attached to the attachment devices 3015 tosecure the suture 3010 to the suture to the papillary muscles.

The suture 3010 is tensioned such that it provides a force that pullsthe papillary muscles PM toward one another. The suture 3010 can betensioned, for example, by twisting the suture 3010 to reduce its theoverall length and thereby reduce the distance between the papillarymuscles PM, and fixing the suture with a crimping element or other stayelement. The amount of twisting or shortening can be varied to vary thetension provided by the suture 3010. In addition, a crimping member maybe used to fix the sutures once a desired tension between the muscles isreached. Exemplary crimping members are described in InternationalPatent Publication Number WO 2003/073913, which is incorporated hereinby reference in its entirety. As in the previous embodiment, therepositioning of the papillary muscles PM re-shapes the left ventricleand/or changes the tension on the chordae CH such that the leaflets LFcontact one another to close the mitral valve. Cuffs or sleeves may beplaced around the papillary muscles PM to such as those previouslydescribed, to affect the repositioning.

With reference now to FIG. 31, the papillary muscles PM can also berepositioned by snaring the papillary muscles. A snare 3110 comprised ofa looped strand of material is positioned around the chordae CH at ornear the location where the chordae attach with the papillary musclesPM. The snare 3110 is tightened to draw the papillary muscles PM towardone another and re-shape the left ventricle and/or changes the distancethat the leaflets need to travel during systole such that the leafletsLF contact one another to close the mitral valve.

In yet another embodiment, shown in FIG. 36, one or more clips 3610 areclipped to each of the papillary muscles PM. The structure of the clips3610 can vary. A tether 3615 attaches the clips 3610 to one another. Thetether 3615 is cinched to shorten the length of the tether 3615 and pullthe papillary muscles PM toward one another and re-shape the leftventricle and/or changes the distance that the leaflets need to travelduring systole such that the leaflets LF contact one another to closethe mitral valve.

In yet another embodiment, shown in FIG. 37, one or more clips 3610 areclipped to opposed walls of the left ventricle LV. The clips 3610 can bedelivered to the left ventricle using a delivery catheter 2105. A tetherattaches the clips to one another. The tether is cinched to shorten thelength of the tether and pull the ventricular walls toward one anotherand re-shape the left ventricle and/or changes the distance that theleaflets need to travel during systole such that the leaflets LF contactone another to close the mitral valve.

In all embodiments, once the papillary muscles are fixed orrepositioned, it may be advantageous to further treat the area byselectively elongating or shortening the chordae tendinae to achievefurther optimal valve function. In addition, a mitral valve clip may bedeployed to augment the desired valve function, either before papillaryor chordal manipulation, or after, if the desired leaflet coaptation isnot achieved with one particular approach.

As discussed above with reference to FIG. 28, a dysfunctional leftventricle can be manifested by excess tension in the chordae CH suchthat a gap is positioned between the valve leaflets LF. It can bedesirable to eliminate or relieve the excess tension by cutting thechordae CH, and/or cutting the chordae and replacing them withartificial chordae. Prior to cutting the chordae, it can be desirable toevaluate the placement of the artificial chordae to confirm thatimplantation of the chordae will indeed provide the desired clinicalresult. This process is now described with reference to FIGS. 32-35.

FIG. 32 shows a leaflet grasping device 1100 that is configured to graspand secure the leaflets of the mitral valve. The device 1100 andcorresponding methods of use are described in more detail in U.S. PatentPublication No. 2004/0030382, entitled “Methods and Apparatus ForCardiac Valve Repair”, which is incorporated herein by reference in itsentirety. Additional leaflet grasping devices are described in U.S.Patent Publication No. 2004/0092962, U.S. Pat. No. 6,269,819, issuedAug. 7, 2001, and U.S. U.S. Pat. No. 6,461,366, issued Oct. 8, 2002, allof which are expressly incorporated by reference herein.

Referring to FIG. 32, the device 1100 is comprised of a catheter shaft1102 having a distal end 1104 and a proximal end 1106. The cathetershaft 1102 is comprised of, among others, a conduit 1108, a coaxialouter sheath 1110, a central lumen 1111 through which a double-jawgrasper 1113 may be inserted, and a central guidewire lumen 1105. Thecatheter shaft 1102 can have additional lumens for the passage of one ormore needles, as described more fully below.

Toward the distal end 1104, an optional pair of stabilizers 1112 arefixedly mounted on the outer sheath 1110 at their proximal end 1114 andfixedly attached to extenders 1116 at their distal end 1118. Thestabilizers 1112 are shown in an outwardly bowed position, however theymay be inwardly collapsed by either extending the extenders 1116 orretracting the outer sheath 1110. Bowing may be achieved by the reverseprocess.

The double-jaw grasper 1113 is comprised of two articulating jaw arms1120 which may be opened and closed against the central shaft 1122(movement depicted by arrows) either independently or in tandem. Thegrasper 1113 is shown in the open position in FIG. 32. The surfaces ofthe jaw arms 1120 and central shaft 1122 may be toothed, as shown, ormay have differing surface textures for varying degrees of friction. Thejaw arms 1120 each include a needle passageway 1121 comprised of acutout or a slot that extends at least partially along the length ofeach jaw arm 1120. As described in more detail below, the needlepassageway provides a location where a needle can pass through the jawarm 1120 during manipulation of the papillary muscle.

The above described components may be manipulated and controlled by ahandle 1126 connected to the proximal end 1106 of the catheter shaft1102, as shown in FIG. 32 the handle 1026 permits independent control ofthe components described above.

Referring to FIGS. 33A-C, the device 1100 may be used at leasttemporarily grasp and restrain the valve leaflets LF of the mitral valveMV. The double-jaw grasper 1113 extends through the valve such that theleaflets LF1, LF2 are grasped from below. Thus, the device 1100 istermed “atrial-ventricular.”

Referring to FIG. 33A, the atrial device 1100 may be stabilized againstthe mitral valve MV. The stabilizers 1112 may be positioned on thesuperior surface of the valve leaflets LF1, LF2 at a 90 degree angle tothe line of coaptation. The grasper 1113 may be advanced in its closedposition from the conduit 1108 between the leaflets LF1, LF2 until thejaw arms 1120 are fully below the leaflets in the ventricle. At thispoint, the grasper 1113 may be opened and retracted so that the jaw arms1120 engage the inferior surface of the leaflets LF1, LF2. In thismanner, the leaflets are secured between the stabilizers 1112 and thejaw arms 1120.

Referring to FIG. 33B, the grasper 1113 will gradually close, drawingthe leaflets LF1, LF2 together while maintaining a secure hold on theleaflets between the jaw arms 1120 and the stabilizers 1112. This may beaccomplished by number of methods. For example, the stabilizers 1112 maybe gradually collapsed by either extending the extenders 1116 orretracting the outer sheath 1110. As the stabilizers 1112 collapse, thejaw arms 1120 may collapse due to spring loading to gradually close thegrasper 1113. Alternatively, the jaw arms 1120 may be actuated to closeagainst the central shaft 1122 applying force to the stabilizers 1112causing them to collapse. In either case, such action allows thestabilizers 1112 to simultaneously vertically retract and withdraw fromthe leaflets as the leaflets are clamped between the jaw arms 1120 andthe central shaft 1122. In this manner, the leaflets are effectively“transferred” to the grasper 1113. Referring to FIG. 33C, once thecollapsed stabilizers 1112 are completely withdrawn, the leaflets LF1,LF2 are held in vertical opposition by the grasper 1113 in a morenatural coaptation geometry.

With reference now to FIG. 34, a needle 3410 is advanced from the leftatrium into the left ventricle. The needle 3410 can be passed through alumen in the device 1100 or it can be passed external to the device1100. In any event, the needle 3410 passes through a leaflet LF and intoa papillary muscle PM. As mentioned, the jaw arms 1120 have needlepassageways 1121 (shown in FIG. 32) that permit passage of the needlethrough the jaw arms 1120.

The needle 3410 is attached to a suture 3415 that extends distallythrough the device 1100. The suture 3415 is then anchored to thepapillary muscle PM such that the suture 3415 provides an attachment forholding, pulling, or otherwise manipulating the papillary muscle PM. Thetension in the suture 3415 can be adjusted to re-position the papillarymuscle PM such that the leaflets LF contact one another to close themitral valve. The same process can be performed with the other papillarymuscle.

With the sutures 3415 holding the papillary muscles PM in a desiredposition, as shown in FIG. 35, the chordae CH may be cut. The sutures3415 function as artificial chordae that retain the leaflets LF andpapillary muscles PM in a desired orientation.

A fixation device such as a clip can then be attached to the leafletsusing methods and device described in U.S. Patent Publication Nos.2004/0030382, filed Aug. 5, 2003, and 2004/0092962, filed May 19, 2003,U.S. Pat. No. 6,269,819, issued Aug. 7, 2001, and U.S. Pat. No.6,461,366, issued Oct. 8, 2002, all of which are expressly incorporatedby reference herein. The sutures 3415 can be attached to the clip 3510or directly to the leaflets LF. It should be appreciated that anyquantity of sutures 3415 can be used as artificial chordae between theleaflets and the papillary muscles. It should be appreciated that theleaflet clips can also be used in conjunction with cutting, elongating,or shortening of the chordae pursuant to the methods described above.

Prior to permanently placing the chordae or clips, the result can bepreviewed on ultrasound (TEE, ICE, echocardiography), to determine ifthe appropriate valve coaptation is restored. In addition, it is withinthe scope of the present invention to implant a mitral valve clip inaddition to performed papillary muscle approximation or chordalimplantation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope of the subject matterdescribed herein. Any recited method can be carried out in the order ofevents recited or in any other order which is logically possible.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theappended claims should not be limited to the description of theembodiments contained herein.

What is claimed is:
 1. A chordal replacement device comprising: aproximal anchor comprising a flexible patch and a leaflet attachmentdevice, wherein the flexible patch is affixed to an upper surface of aportion of a flailing leaflet with the leaflet attachment device; adistal anchor extending and affixed to a distal attachment site in aventricle; and a flexible tether coupled to and tensioned between theproximal and distal anchors.
 2. The device of claim 1, wherein theleaflet attachment device comprises a pair of expandable elementsinterconnected by a central attachment rod.
 3. The device of claim 2,wherein the pair of expandable elements sandwich the flexible patch andthe leaflet.
 4. The device of claim 1, wherein the leaflet attachmentdevice comprises an expandable element.
 5. The device of claim 1,wherein the expandable element is self-deploying.
 6. The device of claim5, wherein the expandable element comprises a star-shaped barb, a meshweb, or a mesh ball.
 7. The device of claim 1, wherein the proximalanchor further comprises a mesh stent deployable within an atrium. 8.The device of claim 7, wherein the mesh stent is coupled to a flexiblerod that extends through a valve commissure into the ventricle.
 9. Thedevice of claim 8, wherein a distal end of the flexible rod couples tothe distal anchor and provides consistent tension on the tether during aheart cycle.
 10. The device of claim 8, wherein the flexible rod has adeflectable, spring-formed shape.
 11. The device of claim 8, wherein theflexible rod is jointed.
 12. The device of claim 1, wherein the distalanchor and tensioned flexible tether apply a downward force on theflailing leaflet.
 13. The device of claim 1, wherein the distal anchorcomprises a weight, barb, adhesive, screw, or fluid-filled element. 14.The device of claim 1, wherein the distal attachment site comprises aportion of the ventricle wall, ventricular septum or papillary muscle.15. The device of claim 14, wherein the distal anchor fine-tunes thetension of the tether after the distal anchor is affixed to the distalattachment site.
 16. The device of claim 15, wherein the distal anchorcomprises a coil screw and wherein rotation of the coil screw fine-tunesthe tension on the tether.
 17. The device of claim 15, wherein thedistal anchor comprises a balloon and wherein infusion of fluid into theballoon increases tension on the tether.
 18. The device of claim 1,wherein the flexible tether has a length that can be adjusted to adesired tension to apply a downward force on the flailing leaflet. 19.The device of claim 1, wherein the flexible tether comprises one or moreloops of a flexible material.
 20. The device of claim 19, wherein theone or more loops are drawn together at a distal end region with anenclosed element.
 21. The device of claim 20, wherein the enclosedelement couples the one or more loops to the distal anchor.
 22. Thedevice of claim 21, wherein the one or more loops are coupled to theproximal and distal anchors such that the one or more loopsself-equalize and evenly distribute tension on the flailing leaflets andon distal attachment site.